Cleared Traditional

K061257 - DBEST HCG PANEL TEST KIT

K061257 is the FDA 510(k) clearance for DBEST HCG PANEL TEST KIT by Ameritek USA, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K061257 · Ameritek USA, Inc. · Chemistry device
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May 2007
Decision
365d
Days
Class 2
Risk

K061257 is an FDA 510(k) clearance for the DBEST HCG PANEL TEST KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ameritek USA, Inc. (Everett, US). The FDA issued a Cleared decision on May 4, 2007 after a review of 365 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 Ameritek USA, Inc. devices

Submission Details

510(k) Number K061257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2006
Decision Date May 04, 2007
Days to Decision 365 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
277d slower than avg
Panel avg: 88d · This submission: 365d
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 K061257.
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K041946 · ACON Laboratories, Inc. · Aug 2004
CLINITEST HCG PREGNANCY TEST
K032563 · Bayer Healthcare, LLC · Dec 2003