(76 days)
The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination of male infertility.
The FertilMARQ™ Test Kit is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples in duplicate. The kit contains components intended to hold, treat, and test collected semen (pre-coated collection cups, disposable pipettes, test cassettes), reagents intended to stain and wash semen samples collected on the test cassette. Positive and negative control wells are incorporated into the cassette design. In addition, the package insert and a Test Results form are included in the Kit. The Kit and all components are stored at room temperature. - The test operates by physical separation of sperm from seminal plasma and other semen components after a sample is dropped onto the filter incorporated into the test cassette. The staining reagent (Thiazine Blue) reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured and vield a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm, as compared to the negative control result, an intrinsic part of the assay.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for FertilMARQ™ Test Kit
This report details the performance of the FertilMARQ™ Test Kit, a semi-quantitative test for rapid sperm concentration analysis, and how it meets its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Test Set) |
|---|---|
| High Sensitivity | 98% (identifying sperm concentration ≥ 20 million/mL) |
| High Specificity | 98% (identifying sperm concentration = 95%"). The reported performance metrics are presented as evidence of equivalence to the predicate device and the standard microscopic method, implying these are the benchmarks for acceptance. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size:
- Clinical Evaluation: 162 semen samples
- Dilution Study: 32 semen samples (19 samples with sperm concentration ≥ 20 million/mL, 13 samples with sperm concentration
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”