Cleared Traditional

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (K052694) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Ind Diagnostic, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 374
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K052694.
Innovita HCG Pregnancy Rapid Combo Test
K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · Aug 2024
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · Hangzhou AllTest Biotech Co., Ltd. · Jan 2022
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · Abbott Laboratories · Feb 1997
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995
AXSYM TOTAL B-HCG
K935673 · Abbott Laboratories · Jun 1994