Cleared Traditional

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY (K853239) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853239 · Haemachem, Inc. · Hematology device
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Nov 1985
Decision
96d
Days
Class 2
Risk

K853239 is an FDA 510(k) clearance for the HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Haemachem, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Haemachem, Inc. devices

Submission Details

510(k) Number K853239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date November 05, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 45
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K853239.
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IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
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K935212 · Instrumentation Laboratory CO · Feb 1994