Cleared Traditional

K931559 - DMA AMYLASE PROCEDURE

K931559 is an FDA 510(k) clearance for DMA AMYLASE PROCEDURE, manufactured by Data Medical Associates, Inc.. The device is a Class 2 Chemistry device with product code CIW cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K931559 · Data Medical Associates, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 1993
Decision
212d
Days
Class 2
Risk

K931559 is an FDA 510(k) clearance for the DMA AMYLASE PROCEDURE. Classified as Starch-dye Bound Polymer, Amylase (product code CIW), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on October 28, 1993 after a review of 212 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K931559

510(k) Number K931559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date October 28, 1993
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIW Device Classification - Class 2, Special Controls

Product Code CIW Starch-dye Bound Polymer, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CIW Starch-dye Bound Polymer, Amylase

All 7
Devices cleared under the same product code (CIW) and FDA review panel - the closest regulatory comparables to K931559.
OLYMPUS AMYLASE REAGENT
K924339 · Olympus Corp. · Oct 1992
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · Em Diagnostic Systems, Inc. · Jan 1989
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K850639 · Bio-Analytics Laboratories, Inc. · Mar 1985
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027 · Eastman Kodak Company · Aug 1981
PHADEBAS ISOAMYLASE TEST
K810584 · Pharmacia, Inc. · May 1981
PANTRAK E.K.
K810669 · Calbiochem-Behring Corp. · Mar 1981