Cleared Traditional

K984076 - INSTANT-VIEW PREGNANCY URINE TEST

K984076 is the FDA 510(k) clearance for INSTANT-VIEW PREGNANCY URINE TEST by Alfa Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K984076 · Alfa Scientific Designs, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
92d
Days
Class 2
Risk

K984076 is an FDA 510(k) clearance for the INSTANT-VIEW PREGNANCY URINE TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 92 days - within the typical 510(k) review window.

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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K984076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date February 16, 1999
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K984076.
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · Sa Scientific, Inc. · May 1999
SAS ONE-STEP PREGNANCY
K990741 · Sa Scientific, Inc. · May 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · Phamatech · Apr 1999
INSTANT-VIEW PREGNANCY COMBO TEST
K984077 · Alfa Scientific Designs, Inc. · Feb 1999
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
K984079 · Alfa Scientific Designs, Inc. · Feb 1999
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
K984080 · Alfa Scientific Designs, Inc. · Feb 1999