Cleared Traditional

PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR (K950164) - FDA 510(k) Clearance

Class I Chemistry device.

K950164 · Abaxis, Inc. · Chemistry device
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Apr 1995
Decision
86d
Days
Class 1
Risk

K950164 is an FDA 510(k) clearance for the PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 Abaxis, Inc. devices

Submission Details

510(k) Number K950164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date April 13, 1995
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 74
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K950164.
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · Boehringer Mannheim Corp. · Mar 1996
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · Data Medical Associates, Inc. · Aug 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995
ROCHE REAGENT
K941573 · Roche Diagnostic Systems, Inc. · Oct 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · Randox Laboratories, Ltd. · Jan 1994
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · Em Diagnostic Systems, Inc. · Dec 1993