Cleared Traditional

K910349 - IMMUNOCORP COATED TUBE IRMA HCG

K910349 is an FDA 510(k) clearance for IMMUNOCORP COATED TUBE IRMA HCG, manufactured by Immunocorp. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K910349 · Immunocorp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
51d
Days
Class 2
Risk

K910349 is an FDA 510(k) clearance for the IMMUNOCORP COATED TUBE IRMA HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Immunocorp (Quebec, Canada, CA). The FDA issued a Cleared decision on March 21, 1991 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Immunocorp devices

FDA 510(k) Submission Details - K910349

510(k) Number K910349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date March 21, 1991
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 294
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K910349.
IMX HCG
K912534 · Abbott Laboratories · Jul 1991
IMX TOTAL B-HCG
K912535 · Abbott Laboratories · Jul 1991
CLEARVIEW HCG SERUM/URINE
K905741 · Unipath , Ltd. · May 1991
TARGET(TM) HOG ONE STEP
K903937 · V-Tech, Inc. · Oct 1990
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · Ciba Corning Diagnostics Corp. · Oct 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · Abbott Laboratories · Sep 1990