Cleared Traditional

K982426 - SPIFE ALKALINE HEMOGLOBIN

K982426 is an FDA 510(k) clearance for SPIFE ALKALINE HEMOGLOBIN, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code JBD cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K982426 · Helena Laboratories · Hematology device
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Dec 1998
Decision
157d
Days
Class 2
Risk

K982426 is an FDA 510(k) clearance for the SPIFE ALKALINE HEMOGLOBIN. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 157 days - an extended review cycle.

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 Helena Laboratories devices

FDA 510(k) Submission Details - K982426

510(k) Number K982426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date December 17, 1998
Days to Decision 157 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
44d slower than avg
Panel avg: 113d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBD Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K982426.
ACID HEMOGLOBIN KIT
K992199 · Helena Laboratories · Sep 1999
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
K991362 · Morax · Jun 1999
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
LABILE REMOVING HEMOLYZING REAGENT
K830804 · Corning Medical & Scientific · May 1983