Cleared Traditional

K965116 - ABBOTT TESTPACK PLUS HCG COMBO WITH OBC

K965116 is an FDA 510(k) clearance for ABBOTT TESTPACK PLUS HCG COMBO WITH OBC, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K965116 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
62d
Days
Class 2
Risk

K965116 is an FDA 510(k) clearance for the ABBOTT TESTPACK PLUS HCG COMBO WITH OBC. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 62 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K965116

510(k) Number K965116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date February 20, 1997
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 K965116.
QUICKVUE ONE-STEP HCG-URINE
K972742 · Quidel Corp. · Aug 1997
CARDS Q.S. HCG-URINE
K972748 · Quidel Corp. · Aug 1997
CLINITEK HCG TEST STRIPS
K971209 · Bayer Corp. · Apr 1997
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
K964461 · Teco Diagnostics · Feb 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462 · Teco Diagnostics · Feb 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · Teco Diagnostics · Feb 1997