Cleared Traditional

K973365 - AIC - CHEK (HBAIC-I)

K973365 is an FDA 510(k) clearance for AIC - CHEK (HBAIC-I), manufactured by Express-Med, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K973365 · Express-Med, Inc. · Hematology device
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Jun 1998
Decision
280d
Days
Class 2
Risk

K973365 is an FDA 510(k) clearance for the AIC - CHEK (HBAIC-I). Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Express-Med, Inc. (Columbus, US). The FDA issued a Cleared decision on June 15, 1998 after a review of 280 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 Express-Med, Inc. devices

FDA 510(k) Submission Details - K973365

510(k) Number K973365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date June 15, 1998
Days to Decision 280 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 113d · This submission: 280d
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 K973365.
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · Genzyme Corp. · Nov 1998
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
K983253 · Medisense, Inc. · Nov 1998
GLYCACOR
K980888 · Exocell, Inc. · Aug 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
K974491 · Boehringer Mannheim Corp. · May 1998
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · Beckman Instruments, Inc. · Nov 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · Tosoh Medics, Inc. · Sep 1997