Cleared Traditional

PREGNANCY, SENSIDEX TUBE TEST (K782063) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K782063 · Ortho Diagnostics, Inc. · Chemistry device
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Apr 1979
Decision
114d
Days
Class 2
Risk

K782063 is an FDA 510(k) clearance for the PREGNANCY, SENSIDEX TUBE TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Ortho Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostics, Inc. devices

Submission Details

510(k) Number K782063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1978
Decision Date April 04, 1979
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 95
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K782063.
SAS(TM) DIRECT MONOCLONAL HCG
K935863 · Sa Scientific, Inc. · Feb 1994
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc. · Jun 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
PREGNANCY TEST KIT, DAISY 2 IN HOME
K790002 · Boehringer Mannheim Corp. · Feb 1979