Cleared Traditional

K951136 - BIONIKE A/Q PREGNANCY TEST

K951136 is an FDA 510(k) clearance for BIONIKE A/Q PREGNANCY TEST, manufactured by Charlton Assoc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K951136 · Charlton Assoc. · Chemistry device
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Apr 1995
Decision
38d
Days
Class 2
Risk

K951136 is an FDA 510(k) clearance for the BIONIKE A/Q PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Charlton Assoc. (Sunnyvale, US). The FDA issued a Cleared decision on April 20, 1995 after a review of 38 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

FDA 510(k) Submission Details - K951136

510(k) Number K951136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date April 20, 1995
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 294
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K951136.
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · Quidel Corp. · Oct 1995
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995
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
VISUALINE II HCG
K943239 · Sun Biomedical Laboratories, Inc. · Dec 1994