Cleared Traditional

K981165 - AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST

K981165 is an FDA 510(k) clearance for AIMSTEP COMBO PREGNANCY, manufactured by Germaine Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K981165 · Germaine Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
16d
Days
Class 2
Risk

K981165 is an FDA 510(k) clearance for the AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Germaine Laboratories, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 16, 1998 after a review of 16 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 Germaine Laboratories, Inc. devices

FDA 510(k) Submission Details - K981165

510(k) Number K981165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1998
Decision Date April 16, 1998
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 252
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K981165.
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
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · Princeton BioMeditech Corp. · Jun 1998
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
K974060 · International Newtech Development, Inc. · Apr 1998
QUICKCARD PRO HCG TEST, MODEL 9008
K980896 · Phamatech · Apr 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · Beckman Instruments, Inc. · Mar 1998