Cleared Traditional

K120945 - HITACHI CLINICAL ANALYZER S TEST REAGEN...

K120945 is an FDA 510(k) clearance for HITACHI CLINICAL ANALYZER S TEST REAGEN..., manufactured by Hitachi Chemical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K120945 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
435d
Days
Class 1
Risk

K120945 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANAL.... Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 7, 2013 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Hitachi Chemical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K120945

510(k) Number K120945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2012
Decision Date June 07, 2013
Days to Decision 435 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
347d slower than avg
Panel avg: 88d · This submission: 435d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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 - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 108
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