Cleared Traditional

K974060 - MINISTRIP/ SERUM AND URINE COMBO HCG TEST

K974060 is an FDA 510(k) clearance for MINISTRIP/ SERUM AND URINE COMBO HCG TEST, 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 164-day FDA review.

K974060 · International Newtech Development, Inc. · Chemistry device
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Apr 1998
Decision
164d
Days
Class 2
Risk

K974060 is an FDA 510(k) clearance for the MINISTRIP/ SERUM AND URINE COMBO HCG TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by International Newtech Development, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on April 9, 1998 after a review of 164 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.

FDA 510(k) Submission Details - K974060

510(k) Number K974060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1997
Decision Date April 09, 1998
Days to Decision 164 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
76d slower than avg
Panel avg: 88d · This submission: 164d
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 334
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K974060.
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
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K980896 · Phamatech · Apr 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · Beckman Instruments, Inc. · Mar 1998
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
K974009 · International Newtech Development, Inc. · Mar 1998
K974060 · MINISTRIP/ SERUM AND URINE COMBO HCG TEST
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