Cleared Traditional

K853722 - PLT-4 PLATELET ANALYZER

K853722 is an FDA 510(k) clearance for PLT-4 PLATELET ANALYZER, manufactured by Texas Intl. Laboratories, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K853722 · Texas Intl. Laboratories, Inc. · Hematology device
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Jan 1986
Decision
134d
Days
Class 2
Risk

K853722 is an FDA 510(k) clearance for the PLT-4 PLATELET ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Texas Intl. Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on January 17, 1986 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Texas Intl. Laboratories, Inc. devices

FDA 510(k) Submission Details - K853722

510(k) Number K853722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1985
Decision Date January 17, 1986
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 113d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 99
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K853722.
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
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