Cleared Traditional

INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K032862) - FDA 510(k) Clearance

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

K032862 · Interlab S.R.L. · Hematology device
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Feb 2004
Decision
144d
Days
Class 2
Risk

K032862 is an FDA 510(k) clearance for the INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Interlab S.R.L. (East Stroudsburg, US). The FDA issued a Cleared decision on February 3, 2004 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7440 - 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

Submission Details

510(k) Number K032862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2003
Decision Date February 03, 2004
Days to Decision 144 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
31d slower than avg
Panel avg: 113d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBD System, Analysis, Electrophoretic Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7440
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 - JBD System, Analysis, Electrophoretic Hemoglobin

All 25
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K032862.
ACID HEMOGLOBIN KIT
K992199 · Helena Laboratories · Sep 1999
SPIFE ALKALINE HEMOGLOBIN
K982426 · Helena Laboratories · Dec 1998
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K931503 · Helena Laboratories · Aug 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
K931465 · Helena Laboratories · Jul 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K901143 · Helena Laboratories · May 1990
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · Helena Laboratories · Dec 1981