Cleared Traditional

K920820 - MODIFICATION COLUMNMATE

K920820 is an FDA 510(k) clearance for MODIFICATION COLUMNMATE, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K920820 · Helena Laboratories · Hematology device
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Aug 1992
Decision
186d
Days
Class 2
Risk

K920820 is an FDA 510(k) clearance for the MODIFICATION COLUMNMATE. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 17, 1992 after a review of 186 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K920820

510(k) Number K920820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1992
Decision Date August 17, 1992
Days to Decision 186 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 113d · This submission: 186d
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 Hematology 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 K920820.
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469 · Bio-Rad · Mar 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
K925204 · Beckman Instruments, Inc. · Jan 1993
IMX(R) GLYCATED HEMOGLOBIN
K921831 · Abbott Laboratories · Sep 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397 · Medical Analysis Systems, Inc. · Aug 1992
POINTE 750 GLYCOMETER
K920449 · Pointe Scientific, Inc., · Jul 1992
COLUMNMATE II
K921676 · Helena Laboratories · Jul 1992