Cleared Traditional

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (K024182) - FDA 510(k) Clearance

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

K024182 · Precision Systems, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
74d
Days
Class 2
Risk

K024182 is an FDA 510(k) clearance for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Precision Systems, Inc. (Natick, US). The FDA issued a Cleared decision on March 3, 2003 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Precision Systems, Inc. devices

Submission Details

510(k) Number K024182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2002
Decision Date March 03, 2003
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 116
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IL TEST(TM) UREA NITROGEN
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BUN (KINETIC)
K895666 · Boehringer Mannheim Corp. · Oct 1989