Cleared Traditional

K021897 - RANDOX HAEMOGLOBIN A1C

K021897 is the FDA 510(k) clearance for RANDOX HAEMOGLOBIN A1C by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K021897 · Randox Laboratories, Ltd. · Chemistry device
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Nov 2002
Decision
169d
Days
Class 2
Risk

K021897 is an FDA 510(k) clearance for the RANDOX HAEMOGLOBIN A1C. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on November 26, 2002 after a review of 169 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K021897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2002
Decision Date November 26, 2002
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 88d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K021897.
D-10 HEMOGLOBIN A1C
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K012410 · Sigma Diagnostics, Inc. · Oct 2001
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K011434 · Tosoh Medics, Inc. · Sep 2001