Cleared Traditional

K020378 - QUPID PLUS E.R.

K020378 is the FDA 510(k) clearance for QUPID PLUS E.R. by Stanbio Laboratory. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K020378 · Stanbio Laboratory · Chemistry device
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Jun 2002
Decision
136d
Days
Class 2
Risk

K020378 is an FDA 510(k) clearance for the QUPID PLUS E.R.. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on June 21, 2002 after a review of 136 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 Stanbio Laboratory devices

Submission Details

510(k) Number K020378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2002
Decision Date June 21, 2002
Days to Decision 136 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
48d slower than avg
Panel avg: 88d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 164
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K020378.
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · Bayer Corp. · Feb 2003
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
STATUS HCG SERUM/URINE
K020439 · Princeton BioMeditech Corp. · May 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · Quidel Corp. · May 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · Quidel Corp. · May 2002