Cleared Traditional

K974009 - PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

K974009 is an FDA 510(k) clearance for PS-UNIT CASSETTE/SERUM AND URINE COMBO 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 143-day FDA review.

K974009 · International Newtech Development, Inc. · Chemistry device
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Mar 1998
Decision
143d
Days
Class 2
Risk

K974009 is an FDA 510(k) clearance for the PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG. 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 March 13, 1998 after a review of 143 days - within the typical 510(k) review window.

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 - K974009

510(k) Number K974009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date March 13, 1998
Days to Decision 143 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
55d slower than avg
Panel avg: 88d · This submission: 143d
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 251
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K974009.
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
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ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
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QUICKSTICK PRO HCG TEST
K974615 · Phamatech · Jan 1998
OSOM HCG-URINE TEST MODEL 101
K974159 · Wyntek Diagnostics, Inc. · Dec 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052 · Quidel Corp. · Dec 1997