Cleared Traditional

ABBOTT VISION GLYCATED HB, MODIFICATION (K936285) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936285 · Abbott Laboratories · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
526d
Days
Class 2
Risk

K936285 is an FDA 510(k) clearance for the ABBOTT VISION GLYCATED HB, MODIFICATION. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 9, 1995 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K936285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date June 09, 1995
Days to Decision 526 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
413d slower than avg
Panel avg: 113d · This submission: 526d
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 89
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K936285.
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · Roche Diagnostic Systems, Inc. · Sep 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
K952337 · Roche Diagnostic Systems, Inc. · Feb 1996
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
K946274 · Helena Laboratories · Jul 1995
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