Cleared Traditional

OLYMPUS AMYLASE REAGENT (K923346) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923346 · Olympus Corp. · Chemistry device
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Oct 1992
Decision
94d
Days
Class 2
Risk

K923346 is an FDA 510(k) clearance for the OLYMPUS AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on October 2, 1992 after a review of 94 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 Olympus Corp. devices

Submission Details

510(k) Number K923346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1992
Decision Date October 02, 1992
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, 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 - JFJ Catalytic Methods, Amylase

All 38
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K923346.
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994
ETHYLIDENE AMYL
K931582 · Em Diagnostic Systems, Inc. · Aug 1993
SILYL AMYL
K931583 · Em Diagnostic Systems, Inc. · Aug 1993
MILES URINE AMYLASE METHOD
K923105 · Heraeus Kulzer, Inc. · Sep 1992
AMYLASE TEST
K923677 · Em Diagnostic Systems, Inc. · Sep 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · Em Diagnostic Systems, Inc. · Mar 1992