Cleared Traditional

K040534 - VITALAB AMYLASE REAGENT

K040534 is an FDA 510(k) clearance for VITALAB AMYLASE REAGENT, manufactured by Clinical Data, Inc.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K040534 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
9d
Days
Class 2
Risk

K040534 is an FDA 510(k) clearance for the VITALAB AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 11, 2004 after a review of 9 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K040534

510(k) Number K040534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date March 11, 2004
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JFJ Catalytic Methods, Amylase

All 92
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K040534.
AMYLASE EPS REAGENT
K070064 · Thermo Fisher Scientific · May 2007
ABX PENTRA AMYLASE CP
K062180 · Horiba Abx · Oct 2006
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · Teco Diagnostics · May 2004
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · Wiener Laboratories Saic · Dec 2002
JAS AMYLASE LIQUID REAGENT
K020282 · Jas Diagnostics, Inc. · Feb 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · Beckman Coulter, Inc. · Jan 2002