Cleared Traditional

K970643 - VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRA...

K970643 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRA... by Johnson & Johnson Clinical Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CHP) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K970643 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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Mar 1997
Decision
26d
Days
Class 1
Risk

K970643 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL.... Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Johnson & Johnson Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K970643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date March 18, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHP Radioimmunoassay, Estradiol

All 32
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K970643.
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · Beckman Instruments, Inc. · Oct 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · Bio-Rad Laboratories, Inc. · Feb 1997
ELECSYS ESTRADIOL ASSAY
K965109 · Boehringer Mannheim Corp. · Feb 1997
VIDAS ESTRADIOL II (E2II) ASSAY
K955647 · Biomerieux Vitek, Inc. · Feb 1996
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697 · Ciba Corning Diagnostics Corp. · Dec 1995
ULTRA-SENSITIVE ESTRADIOL
K953605 · Diagnostic Systems Laboratories, Inc. · Oct 1995