Cleared Traditional

K930823 - PROTEIN-BOUND GLUCOSE ASSAYN KIT

K930823 is the FDA 510(k) clearance for PROTEIN-BOUND GLUCOSE ASSAYN KIT by Diagnostic Specialties. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K930823 · Diagnostic Specialties · Hematology device
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Aug 1993
Decision
183d
Days
Class 2
Risk

K930823 is an FDA 510(k) clearance for the PROTEIN-BOUND GLUCOSE ASSAYN KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on August 19, 1993 after a review of 183 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 Diagnostic Specialties devices

Submission Details

510(k) Number K930823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date August 19, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 113d · This submission: 183d
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 143
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K930823.
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · Heraeus Kulzer, Inc. · Jul 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · Bio-Rad · Apr 1994
GLYCOHEMOGLOBIN
K931183 · Teco Diagnostics · Nov 1993
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