Cleared Traditional

BECKMAN ANTITHROMBIN III REAGENT KIT (K901977) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901977 · Beckman Instruments, Inc. · Hematology device
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Aug 1990
Decision
96d
Days
Class 2
Risk

K901977 is an FDA 510(k) clearance for the BECKMAN ANTITHROMBIN III REAGENT KIT. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 6, 1990 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 864.7060 - 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K901977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date August 06, 1990
Days to Decision 96 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
17d faster than avg
Panel avg: 113d · This submission: 96d
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 Hematology devices follow this clearance model.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 23
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K901977.
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · Sigma Diagnostics, Inc. · Jul 1997
CHROM Z CHROMOGENIC ASSAYS
K951943 · Helena Laboratories · Nov 1995
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · Sigma Diagnostics, Inc. · May 1994
BERICHROM(R) ANTITHROMBIN III
K883662 · Behring Diagnostics, Inc. · Nov 1988
ENZYGNOST(R) TAT REAGENTS
K880700 · Behring Diagnostics, Inc. · Apr 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · Baxter Healthcare Corp · Mar 1988