Cleared Traditional

K951548 - ACE AMYLASE REAGENT

K951548 is an FDA 510(k) clearance for ACE AMYLASE REAGENT, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K951548 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
41d
Days
Class 2
Risk

K951548 is an FDA 510(k) clearance for the ACE AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 41 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 Schiapparelli Biosystems, Inc. devices

FDA 510(k) Submission Details - K951548

510(k) Number K951548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date May 15, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 82
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K951548.
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053 · Diagnostic Chemicals , Ltd. · Dec 1997
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
AMYLASE QVET
K942961 · Prisma Systems · Dec 1994
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994