Cleared Traditional

K130141 - S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

K130141 is an FDA 510(k) clearance for S TEST REAGENT CARTRIDGE ALP (ALKALINE ..., manufactured by Hitachi Chemical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K130141 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
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Mar 2013
Decision
59d
Days
Class 2
Risk

K130141 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE). Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 22, 2013 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 - K130141

510(k) Number K130141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2013
Decision Date March 22, 2013
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 118
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K130141.
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