Cleared Traditional

K780002 - ANTITHROMBIN III ASSAY

K780002 is the FDA 510(k) clearance for ANTITHROMBIN III ASSAY by Ortho Diagnostics, Inc.. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K780002 · Ortho Diagnostics, Inc. · Hematology device
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Jan 1978
Decision
32d
Days
Class 2
Risk

K780002 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 Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1978 after a review of 32 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 Ortho Diagnostics, Inc. devices

Submission Details

510(k) Number K780002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1977
Decision Date January 31, 1978
Days to Decision 32 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 113d · This submission: 32d
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 41
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K780002.
ANTITHROMBIN III ASSAY
K781480 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 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
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K771669 · Abbott Laboratories · Nov 1977