Cleared Traditional

K943239 - VISUALINE II HCG

K943239 is an FDA 510(k) clearance for VISUALINE II HCG, manufactured by Sun Biomedical Laboratories, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K943239

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
Combination Product No
PCCP Authorized No
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.

JHI Device Classification - Class 2, Special Controls

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 286
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K943239.
CONTRAST & RAPID HCG URINE/SERUM TST
K952319 · Medix Biotech, Inc. · Jun 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
K945951 · Syntron Bioresearch, Inc. · Feb 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