Cleared Traditional

K984077 - INSTANT-VIEW PREGNANCY COMBO TEST

K984077 is an FDA 510(k) clearance for INSTANT-VIEW PREGNANCY COMBO TEST, manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K984077 · Alfa Scientific Designs, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
92d
Days
Class 2
Risk

K984077 is an FDA 510(k) clearance for the INSTANT-VIEW PREGNANCY COMBO 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

FDA 510(k) Submission Details - K984077

510(k) Number K984077 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.

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 218
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K984077.
SAS ONE-STEP PREGNANCY
K990741 · Sa Scientific, Inc. · May 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · Phamatech · Apr 1999
INSTANT-VIEW PREGNANCY URINE TEST
K984076 · 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
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
K981444 · Princeton BioMeditech Corp. · Jul 1998