Cleared Traditional

K200754 - Hemosure Accu-Reader A100 (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200754 · W.H.P.M., Inc. · Hematology device
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Jun 2022
Decision
801d
Days
Class 2
Risk

K200754 is an FDA 510(k) clearance for the Hemosure Accu-Reader A100. Classified as Automated Occult Blood Analyzer (product code OOX), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on June 2, 2022 after a review of 801 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all W.H.P.M., Inc. devices

Submission Details

510(k) Number K200754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2020
Decision Date June 02, 2022
Days to Decision 801 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
688d slower than avg
Panel avg: 113d · This submission: 801d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOX Automated Occult Blood Analyzer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
Definition The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding.
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 Hematology devices follow this clearance model.

Regulatory Consultant

Smith Associates
Farokh Etemadieh

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.