Cleared Traditional

K993317 - ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)

K993317 is an FDA 510(k) clearance for ACON HCG ONE STEP PREGNANCY TEST DEVICE..., manufactured by ACON Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K993317 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
58d
Days
Class 2
Risk

K993317 is an FDA 510(k) clearance for the ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE). Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on December 1, 1999 after a review of 58 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 ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K993317

510(k) Number K993317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date December 01, 1999
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

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 287
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K993317.
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · Advantage Diagnostics Corp. · Feb 2000
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · Unipath , Ltd. · Dec 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203 · ACON Laboratories, Inc. · Dec 1999
ONE-STEP DOUBLE-CHEK PREGNANCY TEST
K992915 · Biomedical Products Corp. · Nov 1999
INSURE PRO TEST
K992695 · Inbios Intl., Inc. · Oct 1999
ACON COMBO PREGNANCY
K993065 · ACON Laboratories, Inc. · Oct 1999