Cleared Traditional

K992199 - ACID HEMOGLOBIN KIT

K992199 is the FDA 510(k) clearance for ACID HEMOGLOBIN KIT by Helena Laboratories. It is a Class 2 Hematology device (product code JBD) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K992199 · Helena Laboratories · Hematology device
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Sep 1999
Decision
83d
Days
Class 2
Risk

K992199 is an FDA 510(k) clearance for the ACID HEMOGLOBIN KIT. 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 September 21, 1999 after a review of 83 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 Helena Laboratories devices

Submission Details

510(k) Number K992199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1999
Decision Date September 21, 1999
Days to Decision 83 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
30d faster than avg
Panel avg: 113d · This submission: 83d
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 18
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K992199.
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
LABILE REMOVING HEMOLYZING REAGENT
K830804 · Corning Medical & Scientific · May 1983
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · Helena Laboratories · Dec 1981