Cleared Traditional

K971209 - CLINITEK HCG TEST STRIPS

K971209 is an FDA 510(k) clearance for CLINITEK HCG TEST STRIPS, manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 2-day FDA review.

K971209 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
2d
Days
Class 2
Risk

K971209 is an FDA 510(k) clearance for the CLINITEK HCG TEST STRIPS. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on April 4, 1997 after a review of 2 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 Bayer Corp. devices

FDA 510(k) Submission Details - K971209

510(k) Number K971209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date April 04, 1997
Days to Decision 2 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 88d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Rdd Consultants, Inc.
NANCY SAUER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 287
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K971209.
CARDS Q.S. HCG-URINE
K972748 · Quidel Corp. · Aug 1997
ACCUTEST HCG-URINE
K971886 · Unotech Diagnostics, Inc. · Jun 1997
ACCULINE PREGNANCY TEST
K971122 · Genix Biotek, Inc. · Apr 1997
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
K970424 · Excel Scientific, Inc. · Mar 1997
ACCUPACK PREGNANCY TEST
K964633 · Genix Biotek, Inc. · Feb 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · Abbott Laboratories · Feb 1997