Cleared Traditional

K051841 - WH ACCU TEST ONE-STEP URINE/SERUM COMBO...

K051841 is an FDA 510(k) clearance for WH ACCU TEST ONE-STEP URINE/SERUM COMBO..., manufactured by W.H.P.M., Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K051841 · W.H.P.M., Inc. · Chemistry device
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Aug 2005
Decision
46d
Days
Class 2
Risk

K051841 is an FDA 510(k) clearance for the WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on August 22, 2005 after a review of 46 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 W.H.P.M., Inc. devices

FDA 510(k) Submission Details - K051841

510(k) Number K051841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2005
Decision Date August 22, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 220
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K051841.
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