Cleared Traditional

K941616 - VARIANT TOTAL GHB PROGRAM

K941616 is the FDA 510(k) clearance for VARIANT TOTAL GHB PROGRAM by Bio-Rad. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K941616 · Bio-Rad · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
375d
Days
Class 2
Risk

K941616 is an FDA 510(k) clearance for the VARIANT TOTAL GHB PROGRAM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 375 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bio-Rad devices

Submission Details

510(k) Number K941616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date April 14, 1995
Days to Decision 375 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 113d · This submission: 375d
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 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K941616.
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
K946274 · Helena Laboratories · Jul 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · Abbott Laboratories · Jun 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · Heraeus Kulzer, Inc. · May 1995
TINA-QUANT HEMOGLOBIN A1C
K934070 · Boehringer Mannheim Corp. · Oct 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · Heraeus Kulzer, Inc. · Jul 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · Bio-Rad · Apr 1994