Cleared Traditional

HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) (K991362) - FDA 510(k) Clearance

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

K991362 · Morax · Hematology device
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Jun 1999
Decision
68d
Days
Class 2
Risk

K991362 is an FDA 510(k) clearance for the HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E).... Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Morax devices

Submission Details

510(k) Number K991362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1999
Decision Date June 21, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 113d · This submission: 68d
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 K991362.
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