Cleared Traditional

K162275 - Randox RX Daytona Plus Alkaline Phospha...

K162275 is an FDA 510(k) clearance for Randox RX Daytona Plus Alkaline Phospha..., manufactured by Randox Laboratories Limited. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K162275 · Randox Laboratories Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
252d
Days
Class 2
Risk

K162275 is an FDA 510(k) clearance for the Randox RX Daytona Plus Alkaline Phosphatase (ALP). Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on April 21, 2017 after a review of 252 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories Limited devices

FDA 510(k) Submission Details - K162275

510(k) Number K162275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2016
Decision Date April 21, 2017
Days to Decision 252 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
164d slower than avg
Panel avg: 88d · This submission: 252d
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 90
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K162275.
Alkaline Phosphatase2
K223317 · Abbott Ireland Diagnostics Division · Jul 2023
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · HORIBA ABX SAS · Aug 2019
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
K171971 · Lite-On Technology Corp. H.S.P.B. · Jan 2018
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090 · Medica Corp. · May 2011
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002