Cleared Traditional

K822466 - THROMBIN TIME TEST

K822466 is the FDA 510(k) clearance for THROMBIN TIME TEST by American Dade. It is a Class 2 Hematology device (product code GJA) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K822466 · American Dade · Hematology device
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Sep 1982
Decision
29d
Days
Class 2
Risk

K822466 is an FDA 510(k) clearance for the THROMBIN TIME TEST. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7875 - 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 American Dade devices

Submission Details

510(k) Number K822466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1982
Decision Date September 14, 1982
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJA Test, Thrombin Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7875
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 - GJA Test, Thrombin Time

All 16
Devices cleared under the same product code (GJA) and FDA review panel - the closest regulatory comparables to K822466.
IL SYSTEM 810, ACL AND THE REAGENT SETS
K862301 · Instrumentation Laboratory CO · Sep 1986
THROMBINEX BOVINE THROMBIN
K845000 · Bio/Data Corp. · Mar 1985
THROMBOLYTIC ACTIVITY TEST
K834301 · Bio/Data Corp. · Feb 1984
THROMBIN CLOTTING TIME
K811109 · Bio/Data Corp. · Jul 1981
FIBRI QUIK
K802117 · General Diagnostics · Sep 1980
THROMBOQUIK THROMBIN REAGENT PROD. #3551
K800926 · General Diagnostics · May 1980