Cleared Traditional

PICCOLO CHLORIDE TEST SYSTEM (K010670) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010670 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
51d
Days
Class 2
Risk

K010670 is an FDA 510(k) clearance for the PICCOLO CHLORIDE TEST SYSTEM. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 K010670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date April 26, 2001
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 18
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K010670.
OLYMPUS CHLORIDE REAGENT, MODIFICATION
K934136 · Olympus Corp. · Nov 1993
OLYMPUS CHLORID REAGENT, MODIFIED
K932528 · Olympus Corp. · Sep 1993
OLYMPUS CHLORIDE REAGENT
K925338 · Olympus Corp. · Dec 1992
OLYMPUS CHLORIDE REAGENT
K923610 · Olympus Corp. · Oct 1992
URINE CHLORIDE
K923036 · Heraeus Kulzer, Inc. · Sep 1992
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED
K910133 · Olympus Corp. · Feb 1991