Cleared Traditional

K033297 - ZAP HCG TEST, MODEL 8001

K033297 is an FDA 510(k) clearance for ZAP HCG TEST, manufactured by Zbx Corporation. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K033297 · Zbx Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
156d
Days
Class 2
Risk

K033297 is an FDA 510(k) clearance for the ZAP HCG TEST, MODEL 8001. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Zbx Corporation (Toronto, CA). The FDA issued a Cleared decision on March 18, 2004 after a review of 156 days - an extended review 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: 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.

FDA 510(k) Submission Details - K033297

510(k) Number K033297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date March 18, 2004
Days to Decision 156 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
68d slower than avg
Panel avg: 88d · This submission: 156d
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 358
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K033297.
OSOM HCG COMBO TEST
K043385 · Genzyme Diagnostics · Apr 2005
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc. · Aug 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · Immunostics Inc., · Aug 2004
CLINITEST HCG PREGNANCY TEST
K032563 · Bayer Healthcare, LLC · Dec 2003
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987 · Unotech Diagnostics, Inc. · Nov 2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445 · Mainline Technology, Inc. · Jul 2003
K033297 · ZAP HCG TEST, MODEL 8001
Download PDF FDA Summary Zbx Corporation