Cleared Traditional

K973957 - DBEST ONE-STEP HCG SERUM/URINE TEST

K973957 is the FDA 510(k) clearance for DBEST ONE-STEP HCG SERUM/URINE TEST by Ameritek, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K973957 · Ameritek, Inc. · Chemistry device
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Dec 1997
Decision
62d
Days
Class 2
Risk

K973957 is an FDA 510(k) clearance for the DBEST ONE-STEP HCG SERUM/URINE TEST. 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 December 17, 1997 after a review of 62 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 Ameritek, Inc. devices

Submission Details

510(k) Number K973957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1997
Decision Date December 17, 1997
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 K973957.
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · Beckman Instruments, Inc. · Mar 1998
QUICKSTICK PRO HCG TEST
K974615 · Phamatech · Jan 1998
QUICKVUE SEMI-Q HCG-COMBO
K974052 · Quidel Corp. · Dec 1997
QUICKVUE ONE-STEP HCG-COMBO
K973841 · Quidel Corp. · Dec 1997
CARDS Q.S. HCG SERUM/URINE
K973858 · Quidel Corp. · Nov 1997
QUICKVUE ONE-STEP HCG-URINE
K972742 · Quidel Corp. · Aug 1997