Cleared Traditional

K861667 - ALKALINE PHOSPHATASE PROCEDURE

K861667 is the FDA 510(k) clearance for ALKALINE PHOSPHATASE PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K861667 · Data Medical Associates, Inc. · Chemistry device

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May 1986

Decision

29d

Days

Class 2

Risk

K861667 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE PROCEDURE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on May 29, 1986 after a review of 29 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number	K861667 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 1986
Decision Date	May 29, 1986
Days to Decision	29 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

59d faster than avg

Panel avg: 88d · This submission: 29d

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 K861667.

ALP S.C.E.

K863051 · J. D. Assoc. · Sep 1986

ALP (OPT) REAGENT

K862905 · Sigma Diagnostics, Inc. · Aug 1986

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET

K862256 · Sterling Diagnostics, Inc. · Jul 1986

AP REAGENT CARTRIDGE

K861284 · Hi Chem, Inc. · Apr 1986

ALP (ALKALINE PHOSPHATASE) REAGENT

K860715 · Trace Scientific , Ltd. · Apr 1986

EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT

K860134 · Em Diagnostic Systems, Inc. · Feb 1986

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 K861667

Data Medical Associates, Inc.

Arlington, TX · US

JERRY A GRAHAM

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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