Cleared Traditional

K873250 - ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CON...

K873250 is the FDA 510(k) clearance for ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CON... by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K873250 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1987
Decision
64d
Days
Class 2
Risk

K873250 is an FDA 510(k) clearance for the ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 64 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K873250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date October 20, 1987
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 27
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K873250.
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 1993
BIOTROL AMYLASE CNPG3
K931141 · Biotrol, USA, Inc. · May 1993
-AMYLASE EPS
K882225 · Boehringer Mannheim Corp. · Jan 1989
IL 35260, IL TEST AMYLASE REAGENT
K873572 · Instrumentation Laboratory CO · Oct 1987
BIOTROL ALPHA AMYLASE
K872831 · Biotrol, USA, Inc. · Sep 1987
D.A.T. (TM) AMYLASE REAGENT
K871943 · Behring Diagnostics, Inc. · Jun 1987