Cleared Traditional

K942782 - PICCOLO(TM)

K942782 is an FDA 510(k) clearance for PICCOLO(TM), manufactured by Abaxis, Inc.. The device is a Class 1 Chemistry device with product code JJG cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K942782 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
273d
Days
Class 1
Risk

K942782 is an FDA 510(k) clearance for the PICCOLO(TM). Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 273 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - 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 Abaxis, Inc. devices

FDA 510(k) Submission Details - K942782

510(k) Number K942782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date March 13, 1995
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 88d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 20
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K942782.
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER
K920942 · Olympus Corp. · Jun 1992
COBAS ALPHA
K910222 · Roche Diagnostic Systems, Inc. · Feb 1991
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
K903626 · Beckman Instruments, Inc. · Oct 1990
COBAS FARA II CENTRIFUGAL ANALYZER
K893854 · Roche Diagnostic Systems, Inc. · Aug 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641 · Roche Diagnostic Systems, Inc. · Jul 1989
TECHNICON DAX(TM) SYSTEM
K885203 · Technicon Instruments Corp. · Mar 1989