Cleared Traditional

K803071 - PLA-MATE

K803071 is an FDA 510(k) clearance for PLA-MATE, manufactured by Labex, Inc.. The device is a Class 2 Chemistry device with product code GKL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K803071 · Labex, Inc. · Chemistry device
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Jul 1981
Decision
231d
Days
Class 2
Risk

K803071 is an FDA 510(k) clearance for the PLA-MATE. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Labex, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1981 after a review of 231 days - an extended review cycle.

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

View all Labex, Inc. devices

FDA 510(k) Submission Details - K803071

510(k) Number K803071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1980
Decision Date July 24, 1981
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
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 Chemistry devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 101
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K803071.
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