Cleared Traditional

K132462 - S TEST REAGENT CARTRIDGE BUN AND S TEST...

K132462 is an FDA 510(k) clearance for S TEST REAGENT CARTRIDGE BUN AND S TEST..., manufactured by Hitachi Chemical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CDN cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K132462 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
82d
Days
Class 2
Risk

K132462 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE. Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 28, 2013 after a review of 82 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 Hitachi Chemical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K132462

510(k) Number K132462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date October 28, 2013
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDN Device Classification - Class 2, Special Controls

Product Code CDN Urease, Photometric, 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 - CDN Urease, Photometric, Urea Nitrogen

All 10
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