Cleared Traditional

K984080 - INSTANT-VIEW PREGNANCY COMBO DIP-STRIP ...

K984080 is the FDA 510(k) clearance for INSTANT-VIEW PREGNANCY COMBO DIP-STRIP ... 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.

K984080 · Alfa Scientific Designs, Inc. · Chemistry device
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Feb 1999
Decision
92d
Days
Class 2
Risk

K984080 is an FDA 510(k) clearance for the INSTANT-VIEW PREGNANCY COMBO DIP-STRIP 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 K984080 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 K984080.
INSTANT-VIEW PREGNANCY URINE TEST
K984076 · Alfa Scientific Designs, Inc. · Feb 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
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
K981444 · Princeton BioMeditech Corp. · Jul 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · Princeton BioMeditech Corp. · Jun 1998
QUICKCARD PRO HCG TEST, MODEL 9008
K980896 · Phamatech · Apr 1998