(29 days)
Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided: (a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory; (b.) above mentioned controls are validated for use with the test system being used: (c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.
Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls)
This document is a 510(k) clearance letter from the FDA for a medical device called "Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls)". This type of document does not contain the detailed study information generally associated with device acceptance criteria and performance data.
Here's why and what's typically missing:
- 510(k) Clearance: This is for demonstrating substantial equivalence to a predicate device, not necessarily for proving novel clinical effectiveness or meeting specific performance criteria through a rigorous clinical trial. The focus is on showing the new device is as safe and effective as something already on the market.
- "Control Set" Device: The device itself is a "control set" for Helicobacter pylori IgG antibody immunoassays. This means it's used to verify the performance of other diagnostic tests, not to diagnose patients directly. Therefore, the "acceptance criteria" and "device performance" would relate to its ability to reliably provide positive and negative control results, not to clinical metrics like sensitivity or specificity for H. pylori infection in humans.
- Information Not Included: The letter does not detail any specific studies (e.g., sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets) because that level of detail is typically found in the 510(k) submission itself, not the clearance letter. The letter just confirms the FDA's decision based on that submission.
Therefore, based on the provided text, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details. The document's purpose is to grant market clearance, not to publish an abstract of the underlying performance studies.
If you had access to the full 510(k) submission (which is usually a much larger document than this clearance letter), you might find some of this information.
§ 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).