Cleared Traditional

K021897 - RANDOX HAEMOGLOBIN A1C

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

K021897 · Randox Laboratories, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K021897

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.

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. 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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K021897.
HEMOGLOBIN A1C REAGENT SET
K031539 · Pointe Scientific, Inc., · Aug 2003
GLYCA-DIRECT FRUCTOSAMINE
K023654 · Polymedco, Inc. · May 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003
POLYMEDCO HBA1C TEST
K020532 · Polymedco, Inc. · Apr 2002
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · Dade Behring, Inc. · Nov 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · Sigma Diagnostics, Inc. · Oct 2001