Cleared Traditional

K905709 - BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHO...

K905709 is an FDA 510(k) clearance for BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHO..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K905709 · Beckman Instruments, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
276d
Days
Class 2
Risk

K905709 is an FDA 510(k) clearance for the BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 276 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K905709

510(k) Number K905709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date September 23, 1991
Days to Decision 276 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 113d · This submission: 276d
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 147
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K905709.
GLYCO-TEK AFFINITY COLUMN KIT
K921305 · Helena Laboratories · Jun 1992
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · Boehringer Mannheim Corp. · Dec 1991
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748 · Binax, Inc. · Oct 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625 · Heraeus Kulzer, Inc. · Sep 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · Abbott Laboratories · Feb 1991
GLYC-AFFIN(TM)-GA
K905513 · Isolab, Inc. · Jan 1991