Cleared Traditional

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (K171971) - FDA 510(k) Clearance

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

K171971 · Lite-On Technology Corp. H.S.P.B. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
209d
Days
Class 2
Risk

K171971 is an FDA 510(k) clearance for the Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C3.... Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Lite-On Technology Corp. H.S.P.B. (Hsinchu City, TW). The FDA issued a Cleared decision on January 25, 2018 after a review of 209 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 Lite-On Technology Corp. H.S.P.B. devices

Submission Details

510(k) Number K171971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date January 25, 2018
Days to Decision 209 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
121d slower than avg
Panel avg: 88d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Dynamic Biotech, Inc. Dba. Ivdd Regulatory Consultant
Feng-Yu Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 47
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K171971.
Alkaline Phosphatase
K240468 · Abbott Laboratories Diagnostics Division · Oct 2024
Alkaline Phosphatase2
K223317 · Abbott Ireland Diagnostics Division · Jul 2023
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · HORIBA ABX SAS · Aug 2019
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
K981897 · Roche Diagnostic Systems, Inc. · Aug 1998