Cleared Traditional

K811109 - THROMBIN CLOTTING TIME

K811109 is the FDA 510(k) clearance for THROMBIN CLOTTING TIME by Bio/Data Corp.. It is a Class 2 Hematology device (product code GJA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K811109 · Bio/Data Corp. · Hematology device
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Jul 1981
Decision
84d
Days
Class 2
Risk

K811109 is an FDA 510(k) clearance for the THROMBIN CLOTTING TIME. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 84 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 Bio/Data Corp. devices

Submission Details

510(k) Number K811109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1981
Decision Date July 16, 1981
Days to Decision 84 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
29d faster than avg
Panel avg: 113d · This submission: 84d
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 K811109.
THROMBINEX BOVINE THROMBIN
K845000 · Bio/Data Corp. · Mar 1985
THROMBOLYTIC ACTIVITY TEST
K834301 · Bio/Data Corp. · Feb 1984
THROMBIN TIME TEST
K822466 · American Dade · Sep 1982
FIBRI QUIK
K802117 · General Diagnostics · Sep 1980
THROMBOQUIK THROMBIN REAGENT PROD. #3551
K800926 · General Diagnostics · May 1980
HEPARSORB
K781781 · General Diagnostics · Jan 1979