Cleared Traditional

DADE ANTITHROMBIN III CHROMOGENIC ASSAY (K880315) - FDA 510(k) Clearance

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

K880315 · Baxter Healthcare Corp · Hematology device
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Mar 1988
Decision
50d
Days
Class 2
Risk

K880315 is an FDA 510(k) clearance for the DADE ANTITHROMBIN III CHROMOGENIC ASSAY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on March 16, 1988 after a review of 50 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K880315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date March 16, 1988
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
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 18
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K880315.
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · Beckman Instruments, Inc. · Dec 1997
CHROM Z CHROMOGENIC ASSAYS
K951943 · Helena Laboratories · Nov 1995
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977 · Beckman Instruments, Inc. · Aug 1990
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · Instrumentation Laboratory CO · Nov 1986
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · Instrumentation Laboratory CO · Sep 1984
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1981