Cleared Traditional

K874097 - STACHROM VIII:C TEST KIT

K874097 is the FDA 510(k) clearance for STACHROM VIII:C TEST KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K874097 · American Bioproducts Co. · Hematology device
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Dec 1987
Decision
56d
Days
Class 2
Risk

K874097 is an FDA 510(k) clearance for the STACHROM VIII:C TEST KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on December 3, 1987 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bioproducts Co. devices

Submission Details

510(k) Number K874097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1987
Decision Date December 03, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K874097.
STACHROM ANTIPLASMIN TEST KIT
K882602 · American Bioproducts Co. · Sep 1988
STACHROM ANTIPLASMIN CONTROL
K882603 · American Bioproducts Co. · Sep 1988
CALIBRATION REFERENCE PLASMA
K874940 · Baxter Healthcare Corp · Feb 1988
ASSERACHROM PROTEIN S TEST KIT
K872479 · American Bioproducts Co. · Aug 1987
STACHROM PROTEIN C TEST KIT
K871039 · American Bioproducts Co. · May 1987
PROTEIN S CONTROL PLASMA
K870917 · American Bioproducts Co. · Apr 1987