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510(k) Data Aggregation
(69 days)
POLY STAT HCG TEST
The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
Not Found
The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter from the FDA for a diagnostic device, the Poly stat hCG Test.
However, based on the general nature of an hCG test and the context of a 510(k) submission, we can infer some typical acceptance criteria for such a device and what a study might generally involve, even if the specifics are not in this document.
Inferred Acceptance Criteria and General Study Design (Based on typical IVDDs, not explicitly in the provided text):
The FDA 510(k) clearance states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)." This means the device demonstrated substantial equivalence to a predicate device, which would typically involve performance studies comparing the new device to the predicate and/or to a defined gold standard.
Here's an attempt to answer the questions based on what would typically be required for such a device, acknowledging that these specifics are NOT in the provided document:
1. A table of acceptance criteria and the reported device performance
Since the document does not provide specific acceptance criteria or reported performance metrics, here is an example of what such a table might contain for an hCG test:
| Acceptance Criteria Category | Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Analytical Sensitivity | Detect hCG at ≥ 25 mIU/mL | Detected hCG at 20 mIU/mL |
| Analytical Specificity | No cross-reactivity with LH, FSH, TSH, etc. at specified concentrations | No cross-reactivity observed at tested concentrations |
| Accuracy (Clinical) | ≥95% agreement with predicate device or laboratory reference for positive and negative samples | 98% agreement with laboratory reference |
| Precision (Repeatability) | Consistent results for replicates of low, medium, and high hCG concentrations | CV |
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