Cleared Traditional

K052694 - ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

K052694 is an FDA 510(k) clearance for ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, manufactured by Ind Diagnostic, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K052694 · Ind Diagnostic, Inc. · Chemistry device
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Dec 2005
Decision
79d
Days
Class 2
Risk

K052694 is an FDA 510(k) clearance for the ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on December 16, 2005 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K052694

510(k) Number K052694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date December 16, 2005
Days to Decision 79 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
10d faster than avg
Panel avg: 89d · This submission: 79d
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 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K052694.
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K052694 · ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
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