Cleared Traditional

K853897 - CITREX H

K853897 is the FDA 510(k) clearance for CITREX H by Bio/Data Corp.. It is a Class 2 Hematology device (product code GGW) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K853897 · Bio/Data Corp. · Hematology device
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Oct 1985
Decision
20d
Days
Class 2
Risk

K853897 is an FDA 510(k) clearance for the CITREX H. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 K853897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1985
Decision Date October 10, 1985
Days to Decision 20 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
93d faster than avg
Panel avg: 113d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GGW Test, Time, Partial Thromboplastin

All 20
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K853897.
PLATELET EXTRACT REAGENT
K873382 · Bio/Data Corp. · Nov 1987
ACTIN FSL ACTIVATED PTT REAGENT
K863594 · American Dade · Oct 1986
PTT AUTOMATE TEST KIT
K861190 · American Bioproducts Co. · Jun 1986
CEPHALINEX ACTIVATED PTT REAGENT
K852195 · Bio/Data Corp. · Aug 1985
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
ACTIVAT-PARTIAL THROMBO-PLASTIN
K830320 · Helena Laboratories · Apr 1983