Cleared Traditional

K944229 - OLYMPUS AMYLASE REAGENT

K944229 is an FDA 510(k) clearance for OLYMPUS AMYLASE REAGENT, manufactured by Olympus America, Inc.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K944229 · Olympus America, Inc. · Chemistry device
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Dec 1994
Decision
100d
Days
Class 2
Risk

K944229 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 America, Inc. (Lake Success, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 100 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 America, Inc. devices

FDA 510(k) Submission Details - K944229

510(k) Number K944229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1994
Decision Date December 09, 1994
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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 K944229.
ACE AMYLASE REAGENT
K951548 · Schiapparelli Biosystems, Inc. · May 1995
CATALOGUE NUMBER 321-07/15/50
K945243 · Diagnostic Chemicals , Ltd. · Feb 1995
AMYLASE QVET
K942961 · Prisma Systems · Dec 1994
DUPONT DIMENSION AMYLASE METHOD
K942640 · Dupont Medical Products · Sep 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · Synermed, Inc. · May 1994
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888 · Intersect Systems, Inc. · Jan 1994