Cleared Traditional

K831360 - DATA-ZYME ALKALINE PHOSPHATASE PROCED

K831360 is the FDA 510(k) clearance for DATA-ZYME ALKALINE PHOSPHATASE PROCED by Data Medical Associates, Inc.. It is a Class 2 Microbiology device (product code CJE) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K831360 · Data Medical Associates, Inc. · Microbiology device

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Jun 1983

Decision

43d

Days

Class 2

Risk

K831360 is an FDA 510(k) clearance for the DATA-ZYME ALKALINE PHOSPHATASE PROCED. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1050 - the FDA microbiology device 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number	K831360 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 26, 1983
Decision Date	June 08, 1983
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

59d faster than avg

Panel avg: 102d · This submission: 43d

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 Microbiology 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 K831360.

KINETIC ALKALINE PHOSPHATASE

K834033 · American Monitor Corp. · Jan 1984

RAICHEM ALKALINE PHOSPHATASE REAGENT

K832463 · Reagents Applications, Inc. · Sep 1983

PARAMAX ALKALINE PHOSPHATASE REAGENT-

K831480 · American Dade · Jun 1983

DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI

K823213 · Boehringer Mannheim Corp. · Nov 1982

ULTRAZYME PLUS ALP #64962,65029&65030

K821471 · Emd Chemicals, Inc. · Jun 1982

GILCHEM ALP REAGENT

K812912 · Gilford Diagnostics · Nov 1981

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 K831360

Data Medical Associates, Inc.

Mchenry, IL · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Microbiology

Data Intelligence Layer

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

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