Cleared Traditional

K842499 - NMS 1043 ENZYME IMMUNOASSAY KIT

K842499 is the FDA 510(k) clearance for NMS 1043 ENZYME IMMUNOASSAY KIT by Nms Pharmaceuticals, Inc.. It is a Class 2 Immunology device (product code JHI) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K842499 · Nms Pharmaceuticals, Inc. · Immunology device
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Sep 1984
Decision
80d
Days
Class 2
Risk

K842499 is an FDA 510(k) clearance for the NMS 1043 ENZYME IMMUNOASSAY KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Nms Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology 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 Nms Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K842499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date September 14, 1984
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 104d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Immunology devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K842499.
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082 · Quidel Corp. · Nov 1984
ENCORE HCG REAGENT
K843407 · Hybritech, Inc. · Oct 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · Beckman Instruments, Inc. · Oct 1984
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT
K842692 · Quidel Corp. · Sep 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · Hybritech, Inc. · Aug 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · Travenol Laboratories, S.A. · Jun 1984