Cleared Traditional

K040146 - INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

K040146 is an FDA 510(k) clearance for INTERLAB ACID HEMOGLOBIN ELECTROPHORESI..., manufactured by Interlab S.R.L.. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K040146 · Interlab S.R.L. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
103d
Days
Class 2
Risk

K040146 is an FDA 510(k) clearance for the INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Interlab S.R.L. (East Stroudsburg, US). The FDA issued a Cleared decision on May 4, 2004 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - 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 Interlab S.R.L. devices

FDA 510(k) Submission Details - K040146

510(k) Number K040146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2004
Decision Date May 04, 2004
Days to Decision 103 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 113d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKA Device Classification - Class 2, Special Controls

Product Code GKA Abnormal Hemoglobin Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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 - GKA Abnormal Hemoglobin Quantitation

All 21
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K040146.
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
K052291 · Sebia · Jun 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
K050709 · Wallac OY · Mar 2006
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · Bio-Rad Laboratories, Inc. · May 2005
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 1996
PRIMUS VARIANT SYSTEM PVS99
K955283 · Primus Corp. · Mar 1996
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · Bio-Rad · Nov 1995