Cleared Traditional

K863861 - TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA

K863861 is an FDA 510(k) clearance for TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM..., manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K863861 · Hybritech, Inc. · Chemistry device
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Nov 1986
Decision
49d
Days
Class 2
Risk

K863861 is an FDA 510(k) clearance for the TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 1986 after a review of 49 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 Hybritech, Inc. devices

FDA 510(k) Submission Details - K863861

510(k) Number K863861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date November 21, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 290
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K863861.
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
K865076 · Syntron Bioresearch, Inc. · Feb 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
VIS-CUBE HCG (EIA)
K863933 · Leeco Diagnostics, Inc. · Dec 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · Abbott Laboratories · Sep 1986
CARDS(TM) HCG-URINE
K863199 · Pacific Biotech, Inc. · Sep 1986
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
K862247 · V-Tech, Inc. · Jul 1986