Cleared Traditional

K112101 - FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

K112101 is an FDA 510(k) clearance for FASTEP HCG PREGANCY SERUM/URINE CASSETT..., manufactured by Polymed Therapeutics, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K112101 · Polymed Therapeutics, Inc. · Chemistry device
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Jul 2012
Decision
361d
Days
Class 2
Risk

K112101 is an FDA 510(k) clearance for the FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Polymed Therapeutics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on July 17, 2012 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Polymed Therapeutics, Inc. devices

FDA 510(k) Submission Details - K112101

510(k) Number K112101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2011
Decision Date July 17, 2012
Days to Decision 361 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 88d · This submission: 361d
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 286
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K112101.
FASTEP S10 HCG SERUM/URINE COMBO TEST
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HOME PREGNANCY TEST
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