Cleared Traditional

K771695 - ALKALINE PHOSPHATASE TEST

K771695 is the FDA 510(k) clearance for ALKALINE PHOSPHATASE TEST by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K771695 · Sclavo, Inc. · Chemistry device

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Oct 1977

Decision

42d

Days

Class 2

Risk

K771695 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE TEST. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 18, 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 Sclavo, Inc. devices

Submission Details

510(k) Number	K771695 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 1977
Decision Date	October 18, 1977
Days to Decision	42 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

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 84

Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K771695.

ULTRAZYME PLUS ALP

K780095 · Harleco · Feb 1978

ALP REAGENT SET

K780068 · Medical Analysis Systems, Inc. · Feb 1978

GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP

K772032 · Harleco · Nov 1977

MULTISTAT III ALKALINE PHOSPHATASE

K771470 · Instrumentation Laboratory CO · Sep 1977

DYNAZYME II ALKALINE PHOSPHATASE

K771085 · J.T. Baker Chemical Co. · Aug 1977

ULTRAZYME PLUS ALP

K770870 · Harleco · Jul 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K771695

Sclavo, Inc.

Mchenry, IL · US

Regulatory profile

82 submissions 82 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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