Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff | Guideline Explorer

Description

For questions regarding this document contact Courtney Harper at 301-796-5458 (courtney.harper@fda.hhs.gov). For questions regarding this document as applied to devices regulated by CBER contact Martin Ruta at 301-827-3518

Scope & Applicability

Product Classes

Analyte Specific Reagents

specific requirements for various device types

In Vitro Diagnostic Device

IVDs for emerging pathogens during a Section 564 declared emergency

Class II device

Device classification mentioned regarding novel sterilization methods

Class III device

Included in the scope of home use devices.

General Purpose Reagent

Chemical reagent with general laboratory application defined in 21 CFR 864.4010(a).

LDTs

Laboratory Developed Tests utilizing ASRs

RUO

Research Use Only products

IUO

Investigational Use Only products

Stakeholders

manufacturer

Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.

Test Developer

each test developer should define the specific indications for use for a given test; prominent hyperlink on the test developer’s website; Should calculate accuracy for each variant type

Regulatory Context

Attributes

Class I

The rule classifies most ASRs as Class I devices.

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Related CFR Sections (10)

21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
21CFR809.30§ 809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
(a) Analyte specific reagents (ASR's) ( § 864.4020 of this chapter ) are restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set forth in this section.Read full regulation →
21CFR864.4020§ 864.4020 Analyte specific reagents.
(a) Identification. Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnoRead full regulation →
21CFR807.20§ 807.20 Who must register and submit a device list?
(a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and sRead full regulation →
21CFR864.4010§ 864.4010 General purpose reagent.
(a) A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an iRead full regulation →
21CFR862.1660§ 862.1660 Quality control material (assayed and unassayed).
(a) Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. ARead full regulation →
21CFR862.3280§ 862.3280 Clinical toxicology control material.
(a) Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various sRead full regulation →
21CFR864.8625§ 864.8625 Hematology quality control mixture.
(a) Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean cRead full regulation →
21CFR809.20§ 809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
(a) [Reserved]Read full regulation →
21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →

Related Warning Letters (10)

CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
2025-10-21
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
2025-10-07
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
2025-09-30
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
2025-09-23
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
2025-09-16