Cleared Traditional

ALKALINE PHOSPHATASE (K771829) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771829 · Gamma Enterprises, Inc. · Chemistry device
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Nov 1977
Decision
42d
Days
Class 2
Risk

K771829 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 42 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K771829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1977
Decision Date November 02, 1977
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, 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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 28
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K771829.
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
K823213 · Boehringer Mannheim Corp. · Nov 1982
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
K802574 · Beckman Instruments, Inc. · Nov 1980
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · Beckman Instruments, Inc. · Sep 1978
MULTISTAT III ALKALINE PHOSPHATASE
K771470 · Instrumentation Laboratory CO · Sep 1977
SIGMA PROCED #SC165
K760685 · Sigma Chemical Co. · Nov 1976