Cleared Traditional

K853951 - ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

K853951 is the FDA 510(k) clearance for ISOTRAK AMYLASE TEST AMYLASE ISOENZYME by Behring Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K853951 · Behring Diagnostics, Inc. · Chemistry device
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Jan 1986
Decision
104d
Days
Class 2
Risk

K853951 is an FDA 510(k) clearance for the ISOTRAK AMYLASE TEST AMYLASE ISOENZYME. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on January 7, 1986 after a review of 104 days - within the typical 510(k) review window.

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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K853951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1985
Decision Date January 07, 1986
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, 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 - CIJ Saccharogenic, Amylase

All 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K853951.
DART AMYLASE-D.S. REAGENT SYSTEM
K862370 · Coulter Electronics, Inc. · Aug 1986
AMYLASE PROCEDURE
K861664 · Data Medical Associates, Inc. · Jul 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986
X-AMYLASE ASSAY KIT
K852636 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
SYSTEMATE A AMYLASE HEM 67204
K843645 · Em Diagnostic Systems, Inc. · Sep 1984
DART ALPHA-AMYLASE REAGENT SYSTEM
K834053 · Coulter Electronics, Inc. · Feb 1984