COAG-1 PT-NC Test Card

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904325 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coag-1 Aptt Test Card

  Class II

  FDA 510(k) K891015 Active Cleared 22 May 1989

• Modified Coag-1 Pt Test Card

  Class II

  FDA 510(k) K903019 Active Cleared 1 Aug 1990

• Coag-I Analyzer, Alpha Model

  Class II

  FDA 510(k) K882444 Active Cleared 25 Aug 1988

• Tas Analyzer

  Class II

  FDA 510(k) K933092 Active Cleared 15 Nov 1993

• Dorros-Spring Pressurizer

  Class II

  FDA 510(k) K812304 Active Cleared 13 Oct 1981

• Tas Ptone

  Class II

  FDA 510(k) K955843 Active Cleared 18 Mar 1996

See all devices from Cardiovascular Diagnostic Services →

• What is the COAG-1 PT-NC Test Card used for?

  The COAG-1 PT-NC Test Card is designed for measuring prothrombin time (PT) in blood samples. PT testing assesses the extrinsic pathway of blood clotting, which is essential for monitoring patients on anticoagulant therapy (e.g., warfarin) or diagnosing bleeding disorders. Quantitative results help clinicians adjust treatment plans or evaluate coagulation function.

• How is the COAG-1 PT-NC Test Card supplied and used?

  The COAG-1 PT-NC Test Card is supplied as a single-use, ready-to-use reagent strip. It is compatible with both manual and automated coagulation analyzers, allowing for flexible testing workflows in clinical or point-of-care settings. Each card contains pre-loaded reagents, eliminating the need for additional preparation before use.

• Is the COAG-1 PT-NC Test Card sterile and single-use?

  Yes, the COAG-1 PT-NC Test Card is intended for single-use only. Single-use design ensures patient safety by preventing cross-contamination and maintaining reagent integrity. Sterility is preserved until the card is opened for use, provided it is stored properly (protected from moisture and extreme temperatures).

• What storage conditions are required for the COAG-1 PT-NC Test Card?

  The COAG-1 PT-NC Test Card does not require specialized storage conditions beyond protection from moisture and extreme temperatures. This ensures stability and reliability until the time of use. Store in a dry environment, away from direct sunlight or heat sources, to maintain reagent efficacy.

• What regulatory pathway does the COAG-1 PT-NC Test Card follow?

  The COAG-1 PT-NC Test Card is regulated under the FDA’s 510(k) clearance pathway, specifically classified under device code GJS (Hematology) and adhering to 21 CFR Part 864.7750. It was granted clearance in 1991 (K904325) and is considered substantially equivalent to a predicate device, ensuring compliance with U.S. regulatory standards for coagulation testing.