Cleared Traditional

K921676 - COLUMNMATE II

K921676 is an FDA 510(k) clearance for COLUMNMATE II, 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 93-day FDA review.

K921676 · Helena Laboratories · Hematology device
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Jul 1992
Decision
93d
Days
Class 2
Risk

K921676 is an FDA 510(k) clearance for the COLUMNMATE II. 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 July 10, 1992 after a review of 93 days - within the typical 510(k) review window.

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 - K921676

510(k) Number K921676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date July 10, 1992
Days to Decision 93 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
20d faster than avg
Panel avg: 113d · This submission: 93d
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 K921676.
MODIFICATION COLUMNMATE
K920820 · Helena Laboratories · Aug 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397 · Medical Analysis Systems, Inc. · Aug 1992
POINTE 750 GLYCOMETER
K920449 · Pointe Scientific, Inc., · Jul 1992
GLYCO-TEK AFFINITY COLUMN KIT
K921305 · Helena Laboratories · Jun 1992
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · Boehringer Mannheim Corp. · Dec 1991
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748 · Binax, Inc. · Oct 1991