Cleared Traditional

S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (K131217) - FDA 510(k) Clearance

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

K131217 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
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Jun 2013
Decision
38d
Days
Class 2
Risk

K131217 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 7, 2013 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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

Submission Details

510(k) Number K131217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date June 07, 2013
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 98
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