Cleared Traditional

K771470 - MULTISTAT III ALKALINE PHOSPHATASE

K771470 is an FDA 510(k) clearance for MULTISTAT III ALKALINE PHOSPHATASE, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K771470 · Instrumentation Laboratory CO · Chemistry device
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Sep 1977
Decision
39d
Days
Class 2
Risk

K771470 is an FDA 510(k) clearance for the MULTISTAT III ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 39 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K771470

510(k) Number K771470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date September 12, 1977
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

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 114
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K771470.
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
K772032 · Harleco · Nov 1977
ALKALINE PHOSPHATASE
K771829 · Gamma Enterprises, Inc. · Nov 1977
ALKALINE PHOSPHATASE TEST
K771695 · Sclavo, Inc. · Oct 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085 · J.T. Baker Chemical Co. · Aug 1977
ULTRAZYME PLUS ALP
K770870 · Harleco · Jul 1977
TECHNICON SMA & AAII SYSTEMS
K770406 · Boehringer Laboratories · Jun 1977