Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
This guidance clarifies regulations regarding commercially distributed analyte specific reagents (ASRs) and the role and responsibilities of ASR manufacturers. It addresses frequently asked questions about ASR marketing practices and provides FDA's responses. The guidance focuses on ASRs as building blocks of Laboratory Developed Tests (LDTs) and aims to eliminate confusion regarding particular marketing practices among ASR manufacturers.
What You Need to Know? 👇
What are the key regulatory requirements for commercially distributed ASRs?
ASRs must comply with general controls including cGMP requirements, device registration and listing, medical device reporting, and specific labeling requirements. They cannot include analytical or clinical performance claims and must bear the statement “Analyte Specific Reagent. Analytical and performance characteristics are not established.”
Can ASR manufacturers provide instructions for test development or validation?
No, ASR manufacturers should not provide instructions for developing or performing assays. ASRs are intended as building blocks, and laboratories must independently design, validate, and establish performance characteristics for their tests. Only storage and handling instructions are permitted.
What’s the difference between Class I, II, and III ASRs?
Most ASRs are Class I devices exempt from premarket notification. Class II ASRs are used in blood banking tests. Class III ASRs are for fatal contagious conditions (like HIV/TB) or donor screening tests and require FDA clearance or approval before marketing.
Can multiple ASRs be bundled together and still qualify as ASRs?
No, bundling multiple ASRs together creates an analytical claim that they work together, which disqualifies the product from ASR classification. Each ASR must detect a single target and be sold individually without performance claims or specific test instructions.
Who can purchase commercially distributed ASRs?
ASRs can only be sold to IVD manufacturers, CLIA-qualified clinical laboratories performing high complexity testing, VHA-regulated laboratories, and organizations using reagents for non-diagnostic purposes like forensic, academic, or research applications.
What’s the difference between ASRs and Research Use Only (RUO) products?
ASRs are regulated medical devices subject to cGMP requirements and can be used for clinical diagnostics with proper laboratory validation. RUO products are in early development phases, cannot be used for clinical diagnosis, and are not subject to cGMP requirements.
What You Need to Do 👇
Recommended Actions
- Review current ASR marketing practices to ensure compliance with regulations
- Ensure proper labeling of ASRs without performance claims or instructions for use
- Implement and maintain cGMP system for ASR manufacturing
- Establish process for medical device reporting
- Register and list ASRs with FDA
- Determine proper classification of ASRs (Class I, II, or III)
- Obtain necessary premarket clearance/approval for Class II/III ASRs
- Review sales channels to ensure ASRs are only sold to authorized entities
- Ensure ASRs are not promoted with specific instruments or software
- Maintain clear separation between ASRs and other products (GPRs, controls, etc.)
Key Considerations
Software
- Software cannot be marketed for use with specific ASRs
- If ASR is marketed with software, it’s no longer considered an ASR
Labelling
- Must include statement “Analyte Specific Reagent. Analytical and performance characteristics are not established”
- Must include proper storage and handling instructions
- Cannot include instructions for developing or performing an assay
- Can include scientific information on chemical/molecular composition, concentration, sequence, etc.
- Cannot make clinical or analytical performance claims
Safety
- Must follow current Good Manufacturing Practices (cGMPs)
- Must submit medical device reports
Other considerations
- ASRs can only be sold to IVD manufacturers, CLIA-certified high complexity labs, and research organizations
- Cannot combine or promote multiple ASRs together
- Cannot promote ASRs for use with specific instruments
- Cannot assist laboratories with test validation
- Must register and list devices with FDA
- Some ASRs are Class II or III requiring premarket submission (e.g., blood banking, HIV testing)
Relevant Guidances 🔗
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Laboratory Developed Tests (LDTs) Enforcement Discretion Policy and Phased Compliance Requirements
- Quality System Information Requirements for Premarket Submissions
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
Related references and norms 📂
- 21 CFR Part 820: Quality System Regulation
- 21 CFR 809.10: Labeling for in vitro diagnostic products
- 21 CFR 864.4020: Analyte Specific Reagents
- 42 CFR 493: Laboratory Requirements (CLIA)