Cleared Traditional

K170147 - Lucica Glycated Albumin-L

K170147 is an FDA 510(k) clearance for Lucica Glycated Albumin-L, manufactured by Asahi Kasei Pharma Corporation. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K170147 · Asahi Kasei Pharma Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
268d
Days
Class 2
Risk

K170147 is an FDA 510(k) clearance for the Lucica Glycated Albumin-L. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Asahi Kasei Pharma Corporation (Tokyo, JP). The FDA issued a Cleared decision on October 12, 2017 after a review of 268 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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 Asahi Kasei Pharma Corporation devices

FDA 510(k) Submission Details - K170147

510(k) Number K170147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2017
Decision Date October 12, 2017
Days to Decision 268 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
180d slower than avg
Panel avg: 88d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Regulatory Consultant

Quintilesims
CHRIS SLOAN

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.

Clinical Evidence

ClinicalTrials.gov
NCT02489773 Completed Observational Industry-sponsored

Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

150
Patients (actual)
8
Sites
Condition studied Diabetes
Eligibility All sexes · 18 Years+
Principal investigator Hideji Hiraoka, M.S.
Sponsor Asahi Kasei Therapeutics Corporation (industry)
Started 2015-06-01 → Primary completion 2016-07-01
Primary outcome
Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8
Secondary outcome
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1
View full study on ClinicalTrials.gov

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 208
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