Cleared Traditional

K983726 - GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

K983726 is an FDA 510(k) clearance for GLYPRO REAGENT, manufactured by Genzyme Corp.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K983726 · Genzyme Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
34d
Days
Class 2
Risk

K983726 is an FDA 510(k) clearance for the GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K983726

510(k) Number K983726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date November 25, 1998
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 89d · This submission: 34d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 247
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K983726.
HEMOCHEK SAMPLE COLLECTION KIT
K984529 · Osborn Laboratories, Inc. · Jan 1999
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · Bio-Rad · Dec 1998
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K983172 · Diabetes Technologies, Inc. (Dti) · Nov 1998
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
K983253 · Medisense, Inc. · Nov 1998
GLYCACOR
K980888 · Exocell, Inc. · Aug 1998
AIC - CHEK (HBAIC-I)
K973365 · Express-Med, Inc. · Jun 1998
K983726 · GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
Download PDF FDA Summary Genzyme Corp.