Cleared Traditional

K851636 - DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER ...

K851636 is the FDA 510(k) clearance for DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER ... by Bio-Rad. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K851636 · Bio-Rad · Hematology device
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Jul 1985
Decision
102d
Days
Class 2
Risk

K851636 is an FDA 510(k) clearance for the DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad (Richmond, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 102 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.

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Submission Details

510(k) Number K851636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1985
Decision Date July 30, 1985
Days to Decision 102 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
11d faster than avg
Panel avg: 113d · This submission: 102d
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 Hematology 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 K851636.
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · Bio-Rad · Jul 1987
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · Bio-Rad · Sep 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · Pointe Scientific, Inc., · May 1986
GLYCO-TEK AFFINITY COLUMN
K842689 · Helena Laboratories · Oct 1984
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · Emd Chemicals, Inc. · Jan 1984
AUTO AIC ANALYZER SYSTEM
K833772 · Helena Laboratories · Jan 1984