Cleared Traditional

K853239 - HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY

K853239 is an FDA 510(k) clearance for HEPTEST-A QUANTITATIVE HEPARIN IN PLASM..., manufactured by Haemachem, Inc.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K853239 · Haemachem, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K853239

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.

KFF Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K853239.
ORTHOKROME* HEPARIN
K900396 · Ortho Diagnostic Systems, Inc. · Mar 1990
IL TEST 97575-15, HEPARIN ASSAY
K864211 · Instrumentation Laboratory CO · Jan 1987
HEPANORM CALIBRATION PLASMA SET
K854762 · American Bioproducts Co. · Mar 1986
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · Warner-Lambert Co. · May 1985
HEPARIN ACA ANALYTICAL TEST PACK
K843201 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984
HEPARIN CALIBRATOR ACA
K843202 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984