Cleared Traditional

K951705 - MINISTRIP HCG

K951705 is an FDA 510(k) clearance for MINISTRIP HCG, manufactured by International Newtech Development, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K951705 · International Newtech Development, Inc. · Chemistry device
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Oct 1995
Decision
172d
Days
Class 2
Risk

K951705 is an FDA 510(k) clearance for the MINISTRIP HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by International Newtech Development, Inc. (Richmond, B.C., CA). The FDA issued a Cleared decision on October 3, 1995 after a review of 172 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 International Newtech Development, Inc. devices

FDA 510(k) Submission Details - K951705

510(k) Number K951705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1995
Decision Date October 03, 1995
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
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 252
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K951705.
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · Bio-Rad Laboratories, Inc. · Nov 1995
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