Cleared Traditional

K130200 - PICCOLO TOTAL CHOLESTEROL - CAPILLARY T...

K130200 is an FDA 510(k) clearance for PICCOLO TOTAL CHOLESTEROL - CAPILLARY T..., manufactured by Abaxis, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K130200 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Feb 2013
Decision
18d
Days
Class 1
Risk

K130200 is an FDA 510(k) clearance for the PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on February 15, 2013 after a review of 18 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

FDA 510(k) Submission Details - K130200

510(k) Number K130200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2013
Decision Date February 15, 2013
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 148
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K130200.
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
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CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
K151545 · Polymer Technology Systems, Inc. · Dec 2016
Cholesterol
K150654 · Randox Laboratories, Ltd. · Sep 2015
EASYRA CHOLESTEROL REAGENT
K072249 · Medica Corp. · Feb 2008
PTS PANELS CHOL+HDL PANEL TEST STRIPS
K071593 · Polymer Technology Systems, Inc. · Oct 2007
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
K051376 · Roche Diagnostics · Aug 2005