Cleared Traditional

K942961 - AMYLASE QVET

K942961 is an FDA 510(k) clearance for AMYLASE QVET, manufactured by Prisma Systems. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K942961 · Prisma Systems · Chemistry device
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Dec 1994
Decision
169d
Days
Class 2
Risk

K942961 is an FDA 510(k) clearance for the AMYLASE QVET. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 169 days - an extended review 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: 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 Prisma Systems devices

FDA 510(k) Submission Details - K942961

510(k) Number K942961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 09, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 88d · This submission: 169d
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 79
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K942961.
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250 · Roche Diagnostic Systems, Inc. · Aug 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · Randox Laboratories, Ltd. · Jul 1997
CATALOGUE NUMBER 321-07/15/50
K945243 · Diagnostic Chemicals , Ltd. · Feb 1995
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994
DUPONT DIMENSION AMYLASE METHOD
K942640 · Dupont Medical Products · Sep 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · Synermed, Inc. · May 1994