Cleared Traditional

TINA-QUANT HEMOGLOBIN A1C (K934070) - FDA 510(k) Clearance

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

K934070 · Boehringer Mannheim Corp. · Hematology device
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Oct 1994
Decision
417d
Days
Class 2
Risk

K934070 is an FDA 510(k) clearance for the TINA-QUANT HEMOGLOBIN A1C. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 11, 1994 after a review of 417 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K934070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1993
Decision Date October 11, 1994
Days to Decision 417 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
304d slower than avg
Panel avg: 113d · This submission: 417d
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 85
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K934070.
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · Abbott Laboratories · Jun 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · Heraeus Kulzer, Inc. · May 1995
VARIANT TOTAL GHB PROGRAM
K941616 · Bio-Rad · Apr 1995
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · Heraeus Kulzer, Inc. · Jul 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · Bio-Rad · Apr 1994
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469 · Bio-Rad · Mar 1993