Cleared Traditional

K020439 - STATUS HCG SERUM/URINE

K020439 is an FDA 510(k) clearance for STATUS HCG SERUM/URINE, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K020439 · Princeton BioMeditech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
101d
Days
Class 2
Risk

K020439 is an FDA 510(k) clearance for the STATUS HCG SERUM/URINE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 23, 2002 after a review of 101 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K020439

510(k) Number K020439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date May 23, 2002
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K020439.
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
QUPID PLUS E.R.
K020378 · Stanbio Laboratory · Jun 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · Quidel Corp. · May 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · Quidel Corp. · May 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002