Cleared Traditional

K925303 - PRO-STEP PT HCG

K925303 is an FDA 510(k) clearance for PRO-STEP PT HCG, manufactured by Disease Detection International, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K925303

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
Combination Product No
PCCP Authorized No
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.

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 290
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
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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