Cleared Traditional

K842689 - GLYCO-TEK AFFINITY COLUMN

K842689 is an FDA 510(k) clearance for GLYCO-TEK AFFINITY COLUMN, 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 97-day FDA review.

K842689 · Helena Laboratories · Hematology device
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Oct 1984
Decision
97d
Days
Class 2
Risk

K842689 is an FDA 510(k) clearance for the GLYCO-TEK AFFINITY COLUMN. 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 October 15, 1984 after a review of 97 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 - K842689

510(k) Number K842689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date October 15, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
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 K842689.
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556 · Sandare Chemical Co., Inc. · Aug 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · Pointe Scientific, Inc., · May 1986
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · Bio-Rad · Jul 1985
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · Emd Chemicals, Inc. · Jan 1984
AUTO AIC ANALYZER SYSTEM
K833772 · Helena Laboratories · Jan 1984
GLYCO-JE,E CPMTRP
K833356 · Helena Laboratories · Nov 1983