Cleared Traditional

K113269 - ELITTECH CLINICAL SYSTEMS ALP IFCC SL

K113269 is an FDA 510(k) clearance for ELITTECH CLINICAL SYSTEMS ALP IFCC SL, manufactured by Elitechgroup. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K113269 · Elitechgroup · Chemistry device
Download Printable Device Report (PDF)
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Dec 2011
Decision
55d
Days
Class 2
Risk

K113269 is an FDA 510(k) clearance for the ELITTECH CLINICAL SYSTEMS ALP IFCC SL. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on December 29, 2011 after a review of 55 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 Elitechgroup devices

FDA 510(k) Submission Details - K113269

510(k) Number K113269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2011
Decision Date December 29, 2011
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K113269.
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
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K113436 · Alfa Wassermann · Jul 2012
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090 · Medica Corp. · May 2011
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · Horiba Abx · Jul 2006
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003