K032874 · Biocoat, Inc. · POV · Nov 24, 2003 · Hematology
Device Facts
Record ID
K032874
Device Name
HBA SPERM-HYALURONAN BINDING ASSAY
Applicant
Biocoat, Inc.
Product Code
POV · Hematology
Decision Date
Nov 24, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 864.5220
Device Class
Class 2
Indications for Use
1. As a component of the standard analysis of semen in the diagnosis of suspected male infertility, 2. as a component of analyses for determining the proper course of IVF treatment of infertility.
Device Story
HBA Sperm-Hyaluronan Binding Assay; in vitro diagnostic test for male infertility. Device assesses sperm maturity and functional quality by measuring ability of sperm to bind to hyaluronan, a component of the cumulus oophorus surrounding the oocyte. Sperm sample placed on assay slide coated with hyaluronan; mature, functional sperm bind to hyaluronan; immature or non-functional sperm remain motile. Used in clinical laboratory settings by trained technicians or embryologists. Output provides quantitative or qualitative assessment of sperm binding capacity. Results assist clinicians in diagnosing male factor infertility and selecting appropriate assisted reproductive technology (ART) or IVF treatment pathways.
Clinical Evidence
No clinical data provided in the document.
Technological Characteristics
In vitro diagnostic assay; utilizes hyaluronan-coated slides for sperm binding assessment. Manual microscopic evaluation principle. No electronic or software components described.
Indications for Use
Indicated for use in adult males undergoing semen analysis for suspected infertility or determining IVF treatment courses.
Regulatory Classification
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.
Special Controls
*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.”
Related Devices
K071737 — GENERAL SEMEN ANALYSIS KIT · Dyn-Bioshaf (2006) , Ltd. · Oct 25, 2007
K183602 — SwimCount Sperm Quality Test · Motilitycount Aps · Jun 27, 2019
K983473 — FERTILMARQ TEST KIT · Embryotech Laboratories, Inc. · Dec 17, 1998
Submission Summary (Full Text)
{0}
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K032874
B. Analyte:
HBA Sperm-Hyaluronan Binding Assay
C. Type of Test:
Qualitative assay for the maturity of sperm in a fresh semen sample.
D. Applicant:
Biocoat, Inc.
E. Proprietary and Established Names:
HBA Sperm-Hyaluronan Binding Assay
F. Regulatory Information:
1. Regulation section:
N/A
2. Classification:
Class II
3. Product Code:
MNA
4. Panel:
OB/ GYN, 85
G. Intended Use:
1. Indication(s) for use:
1. As a component of the standard analysis of semen in the diagnosis of suspected male infertility, 2. as a component of analyses for determining the proper course of IVF treatment of infertility.
2. Special condition for use statement(s):
N/A
3. Special instrument Requirements:
N/A
H. Device Description:
The device is a disposable plastic slide with two hyaluronan-coated sperm counting chambers.
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Page 2 of 3
I. Substantial Equivalence Information:
1. Predicate device name(s):
Tru-Trax Cervical Mucous Penetration Assay
2. Predicate K number(s):
K894851
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample | Fresh liquefied semen | Fresh liquefied semen |
| Assay temperature | Room temperature | Room temperature |
| Test Result | Qualitative | Qualitative |
| Intended User | Professional use only | Professional use only |
| Differences | | |
| Item | Device | Predicate |
| Data | Count of bound and unbound motile sperm, viewed under a microscope at 400x. | Linear distance swum by the sperm, viewed under a microscope at 200x. |
| Physiological basis | Binding of sperm to immobilized hyaluronan. | Velocity of sperm in cervical mucous. |
| Assay time | 10-20 minutes | 30 minutes |
J. Standard/Guidance Document Referenced (if applicable):
N/A
K. Test Principle:
The assay is based on the ability of mature, but not immature, sperm to bind hyaluronan, the main mucopolysaccharide of the cumulus oophorus matrix and a component of human follicular fluid.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
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Page 3 of 3
Inter and intra-lot precision with normal specimens was 4.5 to 5.3 % CV. Inter and intra-lot precision with abnormal specimens was 17 to 34 % CV
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
N/A
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A
2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A
3. Clinical studies:
a. Clinical sensitivity:
40 %
b. Clinical specificity:
86%
c. Other clinical supportive data (when a and b are not applicable):
81 % Positive Predictive Value
4. Clinical cut-off:
N/A
5. Expected values/Reference range:
<80% binding=diminished maturity and physiological function. >80% binding=normal maturity and physiological function.
M. Conclusion:
Biocoat, Inc. has demonstrated the HBA Sperm Hyaluronan Binding Assay to be substantially equivalent to the TruTrax Cervical Mucous Penetration Assay.
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