Cleared Traditional

K971919 - EZCHEK/HBA BLOOD COLLECTION KIT

K971919 is the FDA 510(k) clearance for EZCHEK/HBA BLOOD COLLECTION KIT by Flexsite Diagnostics, Inc.. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K971919 · Flexsite Diagnostics, Inc. · Hematology device
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Sep 1997
Decision
105d
Days
Class 2
Risk

K971919 is an FDA 510(k) clearance for the EZCHEK/HBA BLOOD COLLECTION KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Flexsite Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 105 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.

View all Flexsite Diagnostics, Inc. devices

Submission Details

510(k) Number K971919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date September 05, 1997
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
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 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K971919.
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
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · Roche Diagnostic Systems, Inc. · Sep 1996
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K955087 · Bayer Corp. · Jun 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
K952337 · Roche Diagnostic Systems, Inc. · Feb 1996