Cleared Traditional

K925303 - PRO-STEP PT HCG

K925303 is the FDA 510(k) clearance for PRO-STEP PT HCG by Disease Detection International, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K925303 · Disease Detection International, Inc. · Chemistry device
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Jun 1993
Decision
237d
Days
Class 2
Risk

K925303 is an FDA 510(k) clearance for the PRO-STEP PT HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 237 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 Disease Detection International, Inc. devices

Submission Details

510(k) Number K925303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date June 15, 1993
Days to Decision 237 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
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K925303.
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758 · Medix Biotech, Inc. · Sep 1993
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279 · Pb Diagnostic Systems, Inc. · Jul 1993
QUICKVUE ONE-STEP HCG COMBO
K932042 · Quidel Corp. · Jun 1993
SAS PREGNANCY STRIP
K931302 · Sa Scientific, Inc. · Jun 1993
CLEARVIEW HCG
K924673 · Unipath , Ltd. · May 1993
CIBA CORNING ACS HCG IMMUNOASSAY
K925277 · Ciba Corning Diagnostics Corp. · Mar 1993