Cleared Traditional

BODYWISE PREGNANCEY TEST (K941771) - FDA 510(k) Clearance

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

K941771 · Charlton Assoc. · Chemistry device
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Jul 1994
Decision
86d
Days
Class 2
Risk

K941771 is an FDA 510(k) clearance for the BODYWISE PREGNANCEY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Charlton Assoc. (Sunnyvale, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 86 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 Charlton Assoc. devices

Submission Details

510(k) Number K941771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date July 06, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 48
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K941771.
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · Sa Scientific, Inc. · Dec 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories · Jan 1997
PREGNANCY CHECK
K941355 · Sa Scientific, Inc. · Jul 1994
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981 · Abbott Laboratories · Aug 1990