1. FORENSIC USE ONLY PRODUCTS

Products labeled FORENSIC USE ONLY (FUO) are not intended to be used or represented as FDA-cleared clinical diagnostic devices when they do not possess such clearance.

FUO devices are intended for appropriate forensic drugs-of-abuse testing applications.

Appropriate users and settings may include:

• Court systems
• Police departments
• Law-enforcement agencies
• Probation departments
• Parole departments
• Juvenile detention facilities
• Prisons
• Jails
• Correctional facilities
• Appropriate governmental agencies
• Forensic laboratories
• Laboratories conducting appropriate forensic testing
• Other establishments performing forensic testing on behalf of qualifying law-enforcement, correctional, judicial or governmental entities

Products designated Forensic Use Only should be used only in accordance with their applicable labeling and intended use.

2. NOT FOR CLINICAL DIAGNOSIS

A product designated Forensic Use Only is not intended to diagnose, treat, prevent, monitor or identify a disease, illness, medical condition or drug dependency.

An FUO designation must not be represented by a purchaser, reseller or distributor as equivalent to FDA clearance for clinical diagnostic use.

3. AT-HOME AND OVER-THE-COUNTER USE

Unless the particular device is specifically cleared, authorized and labeled for home or Over-the-Counter use, a product labeled Forensic Use Only is not intended to be marketed or sold as a consumer At-Home or OTC diagnostic product in the United States or its territories.

Customers, distributors and resellers are responsible for maintaining the intended-use designation when advertising or redistributing these products.

4. EMPLOYMENT & INSURANCE PRODUCTS

Certain drugs-of-abuse testing devices may be specifically labeled for Employment & Insurance testing.

Where permitted by the specific product’s labeling and regulatory status, Employment & Insurance applications may include certain:

• Pre-employment testing
• Workplace testing
• Random workplace testing
• Reasonable-suspicion or reasonable-cause testing
• Post-accident testing
• Return-to-duty workplace testing
• Insurance-related screening

An Employment & Insurance designation does not automatically apply to every FUO product or every drug-testing product sold by 12 Panel Now.

The specific labeling and intended use of the individual product controls.

5. FEDERAL DRUG-TESTING PROGRAMS

Employment & Insurance products must not automatically be assumed to satisfy the requirements of federally regulated drug-testing programs.

Unless the particular product and testing methodology are authorized for the applicable program, customers must not assume that a general Employment & Insurance drug test is appropriate for federally regulated programs including those involving:

• S. Department of Transportation (DOT)
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• S. Military
• Other federal drug-testing programs having specific regulatory requirements

Customers performing federally regulated testing are responsible for ensuring that the specimen type, collection process, chain-of-custody procedures, laboratory testing, confirmatory testing, Medical Review Officer requirements, reporting and other elements of the testing program comply with applicable federal requirements.

6. SPECIALTY AND EMERGING DRUG TESTS

12 Panel Now carries standard and specialty drug-testing configurations.

Depending upon the particular product, labeling, configuration and regulatory status, products testing for certain specialty or emerging analytes may be designated Forensic Use Only or possess another restricted intended use.

Examples may include products screening for:

• Fentanyl (FEN)
• Xylazine (XYL)
• Tianeptine / ZaZa (TIA)
• Kratom (KRA)
• Synthetic Marijuana / K2 / Spice
• Ethyl Glucuronide / EtG
• Alcohol (ALC)
• Cotinine (COT)
• Ketamine (KET)
• Lysergic Acid Diethylamide (LSD)
• Methaqualone (MQL)
• MDPV / certain synthetic cathinones sometimes referred to as Bath Salts
• Psilocybin / mushroom-related screening configurations
• Other emerging or non-standard drug analytes

The appearance of an analyte on this list does not mean that every test containing that analyte is automatically classified as Forensic Use Only.

Different products testing for the same substance may possess different regulatory classifications.

Always follow the regulatory designation and intended-use labeling of the specific product.

7. FENTANYL PRODUCTS

Fentanyl testing products are available in different formats and may possess different intended uses and regulatory classifications.

Customers should therefore not assume that all fentanyl test strips, cups, dip cards, cartridges or other fentanyl-testing devices have the same regulatory status simply because they detect fentanyl.

The designation applicable to the particular product controls.

8. ORAL FLUID AND SALIVA TESTING

Certain oral-fluid or saliva drug-testing devices and configurations may be designated Forensic Use Only or have other intended-use restrictions.

The regulatory status of a urine-testing device must not be assumed to apply to an oral-fluid device, or vice versa, merely because both devices test for similar substances.

Customers should verify the designation applicable to the specific oral-fluid product.

9. RAPID TESTS PROVIDE SCREENING RESULTS

Unless the applicable product labeling expressly provides otherwise, rapid drugs-of-abuse tests are screening devices.

A preliminary positive, presumptive positive or non-negative screening result should not automatically be regarded as a definitive laboratory-confirmed result.

Where confirmation is required by law, regulation, employer policy, court procedure, correctional policy, insurance program or other applicable standard, confirmatory laboratory testing should be performed using an appropriate confirmatory methodology.

10. COLLECTION AND CHAIN OF CUSTODY

Organizations using drug-testing devices are responsible for implementing collection and handling procedures appropriate for their program.

Depending upon the application, this may include:

• Donor identification
• Specimen integrity procedures
• Chain-of-custody documentation
• Secure specimen handling
• Result documentation
• Laboratory confirmation
• Medical Review Officer review
• Record retention
• Confidentiality
• Reporting procedures

12 Panel Now supplies testing products but does not control the customer’s testing program or individual testing procedures.

11. PRODUCT INSTRUCTIONS CONTROL

Customers must follow all applicable manufacturer instructions, package inserts, cutoff information, warnings, limitations and interpretation requirements.

Website descriptions and general educational information do not replace the official labeling and instructions applicable to the individual device.

12. NO MEDICAL DIAGNOSIS

Rapid screening products should not be used as substitutes for medical diagnosis, clinical evaluation or appropriate laboratory confirmation where such services are necessary.

12 Panel Now does not diagnose medical conditions, substance-use disorders or drug dependency through the sale of a testing device.

13. CUSTOMER RESPONSIBILITY

The purchaser and user are responsible for determining whether the particular product is appropriate and lawful for:

• The intended application
• The intended testing program
• The intended end user
• The applicable jurisdiction
• The type of specimen being tested
• The purpose for which results will be used

Drug-testing requirements can vary based upon federal law, state law, local law, employment rules, correctional requirements, court procedures and other regulatory requirements.

14. DISTRIBUTORS AND RESELLERS

Customers who distribute or resell products purchased from 12 Panel Now are responsible for accurately communicating each product’s intended use and regulatory classification.

Resellers and distributors may not knowingly:

• Remove or conceal an FUO designation
• Represent FUO merchandise as FDA cleared for clinical use when it is not
• Market an FUO product for unauthorized consumer home use
• Make unsupported medical or diagnostic claims
• Change or misrepresent the intended use
• Make regulatory claims not authorized by the applicable product labeling

Resellers remain responsible for independent claims or representations they make to their customers.

15. REGULATORY STATUS MAY DIFFER BETWEEN PRODUCTS

12 Panel Now carries many different configurations, specimen types, panel combinations, specialty analytes and manufacturers.

For this reason, customers should never assume regulatory status based solely upon:

• The number of panels
• Analytes detected
• Product appearance
• Product name
• Cup design
• Test format
• Similarity to another product

The specific product’s regulatory status and labeling controls.

16. PRODUCT PAGE DESIGNATIONS

12 Panel Now makes reasonable efforts to identify relevant product classifications and intended-use restrictions on product pages and/or product documentation.

Customers who believe there is conflicting information between a website description and official product labeling should contact 12 Panel Now before using the product.

Official regulatory labeling applicable to the device takes precedence over general website marketing copy.

17. CUSTOMER ACKNOWLEDGEMENT

By purchasing, receiving, distributing, reselling or using a product designated FORENSIC USE ONLY, EMPLOYMENT & INSURANCE, or otherwise subject to an intended-use restriction, the customer acknowledges and agrees that:

The customer has reviewed or will review the applicable product labeling and intended-use designation.

The customer is responsible for determining whether the product is appropriate for its intended application.

The customer will not knowingly use, advertise, distribute or resell a product in a manner inconsistent with its designated intended use.

The customer is responsible for complying with applicable federal, state and local requirements.

The customer understands that availability for purchase from 12 Panel Now does not mean that every product may be legally used for every application.

The customer understands that similar drug tests may possess different regulatory classifications.

The customer will seek clarification from 12 Panel Now before purchasing or using a product if its intended-use designation is unclear.

18. QUESTIONS REGARDING REGULATORY CLASSIFICATION

If you are uncertain whether a particular product is:

FDA Cleared

CLIA Waived

Forensic Use Only

Employment & Insurance

Professional Use

or subject to another regulatory or intended-use designation, please contact 12 Panel Now before purchasing, distributing, reselling or using the product.

19. CONTACT 12 PANEL NOW

12 Panel Now

801 N Congress Ave., Suite 101
Boynton Beach, FL 33426

Telephone: 561-897-9238

General Customer Service:
[email protected]

Product Classification / Regulatory Questions:
[email protected]

IMPORTANT CUSTOMER NOTICE

A PRODUCT’S SPECIFIC LABELING AND INTENDED-USE DESIGNATION CONTROLS.

Do not assume that one drug-testing device has the same regulatory classification as another device merely because it screens for the same drug or drugs.

By purchasing or using a product labeled Forensic Use Only, Employment & Insurance, or otherwise subject to an intended-use restriction, the purchaser acknowledges responsibility for using and distributing the product consistently with its applicable labeling and applicable law.