Cleared Traditional

K801096 - PERKIN ELMER MODEL 91 AMYLASE REAGENT

K801096 is an FDA 510(k) clearance for PERKIN ELMER MODEL 91 AMYLASE REAGENT, manufactured by Stat Engineering. The device is a Class 2 Chemistry device with product code KHM cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K801096 · Stat Engineering · Chemistry device
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Jun 1980
Decision
31d
Days
Class 2
Risk

K801096 is an FDA 510(k) clearance for the PERKIN ELMER MODEL 91 AMYLASE REAGENT. Classified as Nephelometric, Amylase (product code KHM), Class II - Special Controls.

Submitted by Stat Engineering (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K801096

510(k) Number K801096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1980
Decision Date June 09, 1980
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHM Device Classification - Class 2, Special Controls

Product Code KHM Nephelometric, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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.