Cleared Traditional

K901977 - BECKMAN ANTITHROMBIN III REAGENT KIT

K901977 is an FDA 510(k) clearance for BECKMAN ANTITHROMBIN III REAGENT KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

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

FDA 510(k) Submission Details - K901977

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.

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 41
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K901977.
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
ORTHOKROME* ANTITHROMBIN
K900400 · Ortho Diagnostic Systems, Inc. · Mar 1990
ACTICHROME ATIII KIT
K893608 · American Diagnostic Corp. · Jun 1989
TURBOX ANTITHROMBIN III
K884144 · Unipath , Ltd. · Dec 1988