Cleared Traditional

K871308 - ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT

K871308 is an FDA 510(k) clearance for ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT, manufactured by Allelix, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K871308 · Allelix, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
71d
Days
Class 2
Risk

K871308 is an FDA 510(k) clearance for the ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Allelix, Inc. (Canada L4v 1p1, CA). The FDA issued a Cleared decision on June 11, 1987 after a review of 71 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 Allelix, Inc. devices

FDA 510(k) Submission Details - K871308

510(k) Number K871308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date June 11, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K871308.
BINAX IRMA TOTAL BETA-HCG TEST KIT
K872728 · Binax, Inc. · Aug 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · Syva Co. · Jul 1987
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · Hybritech, Inc. · Jun 1987
AFFINITY (TM) HCG IMMUNIT (TM)
K870627 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
ABBOTT TESTPACK HCG COMBO
K870739 · Abbott Laboratories · May 1987