Cleared Traditional

K781480 - ANTITHROMBIN III ASSAY

K781480 is an FDA 510(k) clearance for ANTITHROMBIN III ASSAY, manufactured by Dade, Baxter Travenol Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K781480 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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Nov 1978
Decision
72d
Days
Class 2
Risk

K781480 is an FDA 510(k) clearance for the ANTITHROMBIN III ASSAY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 72 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 Dade, Baxter Travenol Diagnostics, Inc. devices

FDA 510(k) Submission Details - K781480

510(k) Number K781480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1978
Decision Date November 08, 1978
Days to Decision 72 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
41d faster than avg
Panel avg: 113d · This submission: 72d
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 K781480.
PHADECODE XA INHIBITOR ASSAY
K792019 · Pharmaseal Div., Baxter Healthcare Corp. · Nov 1979
DETERMINATION OF ANTITHROMBIN III, 885
K790090 · Sigma Chemical Co. · Feb 1979
ASSAY, CHROMOGENIC ANTITHROMBIN III
K781860 · Ortho Diagnostics, Inc. · Dec 1978
ANTITHROMBIN III SERUM, ANTI-HUMAN
K781026 · Icl Scientific · Aug 1978
LAS-R HUMAN ANTITHROMBIN III TEST
K772328 · Hyland Therapeutic Div., Travenol Laboratories · Feb 1978
ANTITHROMBIN III ASSAY
K780002 · Ortho Diagnostics, Inc. · Jan 1978