Cleared Traditional

K940971 - AMES DCA 2000 HEMOGLOBIN ALC CONTROLS

K940971 is an FDA 510(k) clearance for AMES DCA 2000 HEMOGLOBIN ALC CONTROLS, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K940971 · Heraeus Kulzer, Inc. · Hematology device
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Jul 1994
Decision
139d
Days
Class 2
Risk

K940971 is an FDA 510(k) clearance for the AMES DCA 2000 HEMOGLOBIN ALC CONTROLS. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 139 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K940971

510(k) Number K940971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1994
Decision Date July 19, 1994
Days to Decision 139 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 113d · This submission: 139d
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 213
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K940971.
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · Heraeus Kulzer, Inc. · May 1995
VARIANT TOTAL GHB PROGRAM
K941616 · Bio-Rad · Apr 1995
TINA-QUANT HEMOGLOBIN A1C
K934070 · Boehringer Mannheim Corp. · Oct 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