Cleared Traditional

K802912 - HELENA AT-III QUIPLATE PROCEDURE

K802912 is the FDA 510(k) clearance for HELENA AT-III QUIPLATE PROCEDURE by Helena Laboratories. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K802912 · Helena Laboratories · Hematology device
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Dec 1980
Decision
34d
Days
Class 2
Risk

K802912 is an FDA 510(k) clearance for the HELENA AT-III QUIPLATE PROCEDURE. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 34 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 Helena Laboratories devices

Submission Details

510(k) Number K802912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1980
Decision Date December 22, 1980
Days to Decision 34 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
79d faster than avg
Panel avg: 113d · This submission: 34d
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 39
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K802912.
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · American Dade · Jun 1983
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1981
ACA ANTITHROMBIN III TEST PACK
K812627 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981
DETERMINATION OF ANTITHROMBIN III, 885
K790090 · Sigma Chemical Co. · Feb 1979
ANTITHROMBIN III ASSAY
K781480 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1978
ANTITHROMBIN III SERUM, ANTI-HUMAN
K781026 · Icl Scientific · Aug 1978