Cleared Traditional

K873572 - IL 35260, IL TEST AMYLASE REAGENT

K873572 is an FDA 510(k) clearance for IL 35260, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code CIJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K873572 · Instrumentation Laboratory CO · Chemistry device
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Oct 1987
Decision
48d
Days
Class 2
Risk

K873572 is an FDA 510(k) clearance for the IL 35260, IL TEST AMYLASE REAGENT. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 48 days - a notably fast clearance 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: 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K873572

510(k) Number K873572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1987
Decision Date October 20, 1987
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIJ Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K873572.
BIOTROL AMYLASE CNPG3
K931141 · Biotrol, USA, Inc. · May 1993
-AMYLASE EPS
K882225 · Boehringer Mannheim Corp. · Jan 1989
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · Roche Diagnostic Systems, Inc. · Oct 1987
BIOTROL ALPHA AMYLASE
K872831 · Biotrol, USA, Inc. · Sep 1987
D.A.T. (TM) AMYLASE REAGENT
K871943 · Behring Diagnostics, Inc. · Jun 1987
AMYLASE REAGENT
K864356 · Trace Scientific , Ltd. · Jan 1987