Cleared Traditional

K850902 - DATA ZYME ACID PHOSPHATASE PROCEDURE

K850902 is the FDA 510(k) clearance for DATA ZYME ACID PHOSPHATASE PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CKB) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K850902 · Data Medical Associates, Inc. · Chemistry device

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Mar 1985

Decision

15d

Days

Class 2

Risk

K850902 is an FDA 510(k) clearance for the DATA ZYME ACID PHOSPHATASE PROCEDURE. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - 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	K850902 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1985
Decision Date	March 20, 1985
Days to Decision	15 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

73d faster than avg

Panel avg: 88d · This submission: 15d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CKB Acid Phosphatase, Naphthyl Phosphate
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1020

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 - CKB Acid Phosphatase, Naphthyl Phosphate

All 16

Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K850902.

ACID PHOSPHATASE (KINETIC) CAT. # 320-06

K875209 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988

ACID PHOSPHATASE (ACP) REAGENT

K863851 · Sigma Diagnostics, Inc. · Oct 1986

ACID PHOSPHATASE PROCEDURE

K861675 · Data Medical Associates, Inc. · May 1986

PARAMAX ACID PHOSPHATASE REAGENT

K840661 · American Dade · Apr 1984

RAICHEM ACID PHASPHATASE REAGENT

K831834 · Reagents Applications, Inc. · Aug 1983

BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA

K823087 · Boehringer Mannheim Corp. · Nov 1982

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 K850902

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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