Cleared Traditional

K832592 - DIACROM * ATIII

K832592 is the FDA 510(k) clearance for DIACROM * ATIII by Wellcome Diagnostics. It is a Class 2 Immunology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K832592 · Wellcome Diagnostics · Immunology device
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Sep 1983
Decision
58d
Days
Class 2
Risk

K832592 is an FDA 510(k) clearance for the DIACROM * ATIII. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.7060 - the FDA immunology 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.

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Submission Details

510(k) Number K832592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date September 29, 1983
Days to Decision 58 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 104d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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 Immunology devices follow this clearance model.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 40
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K832592.
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · Instrumentation Laboratory CO · Nov 1986
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · Warner-Lambert Co. · May 1985
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · Instrumentation Laboratory CO · Sep 1984
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961 · Kent Laboratories, Inc. · Aug 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · American Dade · Jun 1983
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1981