Cleared Traditional

K923105 - MILES URINE AMYLASE METHOD

K923105 is an FDA 510(k) clearance for MILES URINE AMYLASE METHOD, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K923105 · Heraeus Kulzer, Inc. · Chemistry device
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Sep 1992
Decision
101d
Days
Class 2
Risk

K923105 is an FDA 510(k) clearance for the MILES URINE AMYLASE METHOD. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 28, 1992 after a review of 101 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K923105

510(k) Number K923105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1992
Decision Date September 28, 1992
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFJ Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K923105.
SILYL AMYL
K931583 · Em Diagnostic Systems, Inc. · Aug 1993
LIQUID AMYLASE REAGENT SET
K930475 · Pointe Scientific, Inc., · Jul 1993
OLYMPUS AMYLASE REAGENT
K923346 · Olympus Corp. · Oct 1992
AMYLASE TEST
K923677 · Em Diagnostic Systems, Inc. · Sep 1992
AMYLASE REAGENT
K921057 · Genzyme Corp. · Mar 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · Em Diagnostic Systems, Inc. · Mar 1992