Cleared Abbreviated

K001215 - DBEST HCG 2 IU/ML TEST KIT

K001215 is the FDA 510(k) clearance for DBEST HCG 2 IU/ML TEST KIT by Ameritek, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Abbreviated 510(k) pathway after a 69-day FDA review.

K001215 · Ameritek, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
69d
Days
Class 2
Risk

K001215 is an FDA 510(k) clearance for the DBEST HCG 2 IU/ML TEST KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on June 22, 2000 after a review of 69 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ameritek, Inc. devices

Submission Details

510(k) Number K001215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2000
Decision Date June 22, 2000
Days to Decision 69 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Standards-based clearance path.

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 K001215.
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc. · Mar 2002
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · Sa Scientific, Inc. · Apr 2001
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · Unipath , Ltd. · Dec 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203 · ACON Laboratories, Inc. · Dec 1999
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317 · ACON Laboratories, Inc. · Dec 1999