Cleared Traditional

K972144 - SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III

K972144 is an FDA 510(k) clearance for SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBI..., manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K972144 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
49d
Days
Class 2
Risk

K972144 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 25, 1997 after a review of 49 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.

View all Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K972144

510(k) Number K972144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date July 25, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 113d · This submission: 49d
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 47
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K972144.
K-ASSAY AT-III
K000361 · Kamiya Biomedical Co. · Apr 2000
IL TEST ANTITHROMBIN
K980499 · Instrumentation Laboratory CO · Apr 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · Beckman Instruments, Inc. · Dec 1997
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · Medical Diagnostic Technologies, Inc. · Aug 1996
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
K952515 · Chromogenix AB · Jan 1996
CHROM Z CHROMOGENIC ASSAYS
K951943 · Helena Laboratories · Nov 1995