Cleared Traditional

K770155 - ALKALINE PHOSPHATASE ISOYZME REAGENT SET

K770155 is the FDA 510(k) clearance for ALKALINE PHOSPHATASE ISOYZME REAGENT SET by Gelman Instrument Co.. It is a Class 2 Chemistry device (product code CJO) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770155 · Gelman Instrument Co. · Chemistry device
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Jan 1977
Decision
7d
Days
Class 2
Risk

K770155 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE ISOYZME REAGENT SET. Classified as Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (product code CJO), Class II - Special Controls.

Submitted by Gelman Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Gelman Instrument Co. devices

Submission Details

510(k) Number K770155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1977
Decision Date January 31, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 88d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJO Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJO Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

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