Cleared Traditional

KINGS BAY PRELUDE ONE STEP HCG COMBO KIT (K931698) - FDA 510(k) Clearance

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

K931698 · King'S Bay Intl., Inc. · Chemistry device
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Nov 1993
Decision
213d
Days
Class 2
Risk

K931698 is an FDA 510(k) clearance for the KINGS BAY PRELUDE ONE STEP HCG COMBO KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by King'S Bay Intl., Inc. (Vista, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 213 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 King'S Bay Intl., Inc. devices

Submission Details

510(k) Number K931698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date November 05, 1993
Days to Decision 213 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 88d · This submission: 213d
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 59
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K931698.
AXSYM TOTAL B-HCG
K935673 · Abbott Laboratories · Jun 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
K936138 · Eastman Kodak Company · Apr 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287 · Eastman Kodak Company · Apr 1994
SAS PREGNANCY STRIP
K931302 · Sa Scientific, Inc. · Jun 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342 · Syva Co. · Feb 1993
SAS ONE STEP PREGNANCY
K926204 · Sa Scientific, Inc. · Feb 1993