Cleared Traditional

K943239 - VISUALINE II HCG

K943239 is the FDA 510(k) clearance for VISUALINE II HCG by Sun Biomedical Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K943239 · Sun Biomedical Laboratories, Inc. · Chemistry device
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Dec 1994
Decision
154d
Days
Class 2
Risk

K943239 is an FDA 510(k) clearance for the VISUALINE II HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Sun Biomedical Laboratories, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 154 days - an extended review 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: 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 Sun Biomedical Laboratories, Inc. devices

Submission Details

510(k) Number K943239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date December 07, 1994
Days to Decision 154 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
66d slower than avg
Panel avg: 88d · This submission: 154d
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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K943239.
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319 · Medix Biotech, Inc. · Jun 1995
RAPIDVUE(TM) HCG
K945969 · Quidel Corp. · Jan 1995
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426 · Princeton BioMeditech Corp. · Oct 1994
AXSYM TOTAL B-HCG
K935673 · Abbott Laboratories · Jun 1994
ONE STEP PREGNANCY TEST
K936031 · Teco Diagnostics · Apr 1994