# K092817: Poc-AS10 Auto Sampler

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka Pharmaceutical Co., Ltd.
- Decided: Mar 9, 2010 after 176 days
- Product code: MSQ (Test, Urea (Breath Or Blood))
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) POCone Infrared Spectrophotometer: named in the summary without a submission number
- (no number) UBiT-1R300 Infrared Spectrometry System: named in the summary without a submission number

## Indications for use
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13C0 2 content in breath CO 2 gas by infrared spectroscopic analysis.. The POC-AS 10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. The POCone hifirared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13 C-urea breath tests for the detection of Helicobacterpylori (H.pylori) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.

Source page: https://510kreport.com/device/K092817
Methodology: https://510kreport.com/methodology