Cleared Traditional

K865057 - TANDEMR ICONR II HCG(SERUM) IMMUNOENZYM...

K865057 is the FDA 510(k) clearance for TANDEMR ICONR II HCG(SERUM) IMMUNOENZYM... by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K865057 · Hybritech, Inc. · Chemistry device
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Mar 1987
Decision
76d
Days
Class 2
Risk

K865057 is an FDA 510(k) clearance for the TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY. 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 March 10, 1987 after a review of 76 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

Submission Details

510(k) Number K865057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1986
Decision Date March 10, 1987
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K865057.
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · Hybritech, Inc. · Apr 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · Diagnostic Products Corp. · Mar 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · Leeco Diagnostics, Inc. · Mar 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