(301 days)
The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins. The test is intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE) .
The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins.
The provided text is a 510(k) clearance letter from the FDA for a device called "FHCRC Anti-SR Test." This letter grants clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data that would be found in a 510(k) submission document itself.
Therefore,Based on the provided document, I cannot extract the acceptance criteria or a study proving the device meets those criteria. The document is solely an FDA clearance letter, which references a 510(k) premarket notification but does not contain the specifics of that submission.
Here's why the requested information cannot be found in the provided text:
- No Acceptance Criteria or Performance Data: The letter states the device is "substantially equivalent" to a predicate device but does not detail the specific performance metrics (like sensitivity, specificity, accuracy) or the thresholds for those metrics that would constitute "acceptance criteria."
- No Description of a Study: While a study would have been part of the 510(k) submission that led to this letter, the letter itself does not describe the study design, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly mentions:
- Trade/Device Name: Fred Hutchinson Cancer Research Center (FHCRC) Anti-SR Test
- Regulation Name: Antinuclear Antibody Immunological Test System
- Indications For Use: An enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against SR Proteins, intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE).
To answer your request, one would need access to the original 510(k) submission for device K013263.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).