Cleared Traditional

K915706 - LIPASE REAGENT SET

K915706 is an FDA 510(k) clearance for LIPASE REAGENT SET, manufactured by Tech Intl. Co.. The device is a Class 1 Chemistry device with product code CET cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K915706 · Tech Intl. Co. · Chemistry device
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Feb 1992
Decision
81d
Days
Class 1
Risk

K915706 is an FDA 510(k) clearance for the LIPASE REAGENT SET. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1465 - 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.

View all Tech Intl. Co. devices

FDA 510(k) Submission Details - K915706

510(k) Number K915706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date February 18, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

CET Device Classification - Class 1, General Controls

Product Code CET Olive Oil Emulsion (turbidimetric), Lipase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1465
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CET Olive Oil Emulsion (turbidimetric), Lipase

All 12
Devices cleared under the same product code (CET) and FDA review panel - the closest regulatory comparables to K915706.
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