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K Number
K952220
Device Name
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
Manufacturer
MERETEK DIAGNOSTICS, INC.
Date Cleared
1996-09-17

(495 days)

Product Code
LYR
Regulation Number
866.3110
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called MERETEK UBT™. While it confirms the device's substantial equivalence and outlines regulatory requirements, it does not contain any information regarding the acceptance criteria for a study, nor does it present data from a study that proves the device meets those criteria.

The letter explicitly states: "Our substantially equivalent determination does not apply to the drug component (NDA 20-586) of your product." It then directs the manufacturer to contact the Center for Drug Evaluation and Research for information on applicable Agency requirements for marketing the drug component. This indicates that the clinical effectiveness and associated studies for the drug component, which is likely central to the device's function, would be handled under a separate NDA process, not detailed here.

Therefore, I cannot provide the requested information from the given text.

The document is solely a regulatory clearance letter and does not include scientific study details such as:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method: Not present.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
  6. Standalone performance study details: Not present.
  7. Type of ground truth used: Not present.
  8. Sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).