Cleared Traditional

K935308 - ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY

K935308 is an FDA 510(k) clearance for ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGE..., 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 196-day FDA review.

K935308 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
196d
Days
Class 2
Risk

K935308 is an FDA 510(k) clearance for the ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY. 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 May 17, 1994 after a review of 196 days - an extended review 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: 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K935308

510(k) Number K935308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date May 17, 1994
Days to Decision 196 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 113d · This submission: 196d
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 K935308.
CHROM Z CHROMOGENIC ASSAYS
K951943 · Helena Laboratories · Nov 1995
AT-III CALIBRATOR
K944279 · American Bioproducts Co. · Apr 1995
BIOMERIEUX HEMOLAB AT III
K934156 · Biomerieux Vitek, Inc. · Dec 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · Baxter Diagnostics, Inc. · May 1994
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667 · The Binding Site, Ltd. · Jan 1992
LIATEST(R) AT III TEST KIT
K905110 · American Bioproducts Co. · Jan 1991