Cleared Traditional

K832268 - RABBIT ANTI-HUMAN ANTITHROMBIN III

K832268 is an FDA 510(k) clearance for RABBIT ANTI-HUMAN ANTITHROMBIN III, manufactured by Gelco Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K832268 · Gelco Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
43d
Days
Class 2
Risk

K832268 is an FDA 510(k) clearance for the RABBIT ANTI-HUMAN ANTITHROMBIN III. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Gelco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 43 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K832268

510(k) Number K832268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date August 12, 1983
Days to Decision 43 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
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBQ Device Classification - Class 2, Special Controls

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 Hematology devices follow this clearance model.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 54
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K832268.
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · Warner-Lambert Co. · May 1985
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · Instrumentation Laboratory CO · Sep 1984
DIACROM * ATIII
K832592 · Wellcome Diagnostics · Sep 1983
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961 · Kent Laboratories, Inc. · Aug 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · American Dade · Jun 1983
COATEST ANTITHROMBIN
K812829 · Kabivitrum, Inc. · Dec 1981
K832268 · RABBIT ANTI-HUMAN ANTITHROMBIN III
Download PDF Gelco Diagnostics, In…