Cleared Traditional

K831297 - PROTOTRO/PROTEOLYTIC ENZYME CONTROL

K831297 is the FDA 510(k) clearance for PROTOTRO/PROTEOLYTIC ENZYME CONTROL by American Dade. It is a Class 2 Chemistry device (product code JBQ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831297 · American Dade · Chemistry device
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Jun 1983
Decision
48d
Days
Class 2
Risk

K831297 is an FDA 510(k) clearance for the PROTOTRO/PROTEOLYTIC ENZYME CONTROL. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7060 - the FDA in vitro diagnostics and chemistry 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 American Dade devices

Submission Details

510(k) Number K831297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1983
Decision Date June 08, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 Chemistry 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 K831297.
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · Warner-Lambert Co. · May 1985
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · Instrumentation Laboratory CO · Sep 1984
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961 · Kent Laboratories, Inc. · Aug 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
HELENA AT-III QUIPLATE PROCEDURE
K802912 · Helena Laboratories · Dec 1980