# K200754: Hemosure Accu-Reader A100

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: Jun 2, 2022 after 801 days
- Product code: OOX (Automated Occult Blood Analyzer)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041408 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041408: Polymedco OC Auto Micro 80 Fob Test, Polymedco, Inc. (2004) Summary page 4.

## Indications for use
Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit. For in vitro diagnostic use. For Prescription use.

Source page: https://510kreport.com/device/K200754
Methodology: https://510kreport.com/methodology