Cleared Traditional

K974059 - ONE STEP MIDSTREAM HCG PREGNANCY TEST

K974059 is an FDA 510(k) clearance for ONE STEP MIDSTREAM HCG PREGNANCY TEST, manufactured by International Newtech Development, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K974059 · International Newtech Development, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
164d
Days
Class 2
Risk

K974059 is an FDA 510(k) clearance for the ONE STEP MIDSTREAM HCG PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), 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.

View all International Newtech Development, Inc. devices

FDA 510(k) Submission Details - K974059

510(k) Number K974059 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.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 135
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K974059.
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
K984075 · Alfa Scientific Designs, Inc. · Feb 1999
ACON MIDSTREAM PREGNANCY TEST
K983090 · ACON Laboratories, Inc. · Nov 1998
QUIDEL HOME PREGNANCY TEST
K981722 · Quidel Corp. · Jun 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532 · Phamatech · Mar 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · Quidel Corp. · Jan 1998
SIGNAL PREGNANCY TEST KIT
K974021 · Sa Scientific, Inc. · Dec 1997