Cleared Traditional

K852111 - GLYCO-CHECK

K852111 is an FDA 510(k) clearance for GLYCO-CHECK, manufactured by Thyroid Diagnostics, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K852111 · Thyroid Diagnostics, Inc. · Hematology device
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Jul 1985
Decision
51d
Days
Class 2
Risk

K852111 is an FDA 510(k) clearance for the GLYCO-CHECK. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Thyroid Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thyroid Diagnostics, Inc. devices

FDA 510(k) Submission Details - K852111

510(k) Number K852111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date July 05, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
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 211
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K852111.
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
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