HBA SPERM-HYALURONAN BINDING ASSAY

• K Number: K032874
• Device Name: HBA SPERM-HYALURONAN BINDING ASSAY
• Manufacturer: BIOCOAT, INC.
• Date Cleared: 2003-11-24 ( 70 days)
• Product Code: POV GKZ
• Regulation Number: 864.5220

Intended 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 Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

Therapeutic

No.
The device is used for diagnosis and analysis of infertility, not for treating it.

Diagnostic

Yes
The intended use statement explicitly mentions "diagnosis of suspected male infertility" and "determining the proper course of IVF treatment of infertility," which are diagnostic purposes.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is likely an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended uses clearly state that the device is used as a component of the analysis of semen for the diagnosis of suspected male infertility and for determining the proper course of IVF treatment. These are diagnostic purposes performed on a biological sample (semen) taken from the human body.

• Nature of the Sample: Semen is a biological specimen obtained from a human.

• Purpose of the Analysis: The analysis is aimed at providing information about a person's health status (infertility) and guiding medical treatment (IVF).

While the "Device Description" is not found, the intended use alone strongly indicates that this device is designed to be used in vitro (outside the body) to examine a biological sample for diagnostic purposes.

The lack of information about image processing, AI, input imaging modality, etc., doesn't negate its likely IVD status. Many IVDs don't involve these technologies.

Therefore, based on the provided intended use, this device fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

GKZ

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.”

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.

10903 New Hampshire Avenue Silver Spring, MD 20993

DEC 2-1- 2012

Biocoat Inc. c/o James Johnston, Ph.D. Principal Investigator 455 Pensylvania Avenue, Suite 120 Ft. Washington, Pennsylvania 19034

Re: K032874

Trade/Device Name: HBA Sperm-Hyaluronan Binding Assay Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: September 9, 2003 Received: September 17, 2003

Dear Dr. Johnston:

This letter corrects our substantially equivalent letter of November 24, 2003.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

1

Page 2 - James Johnston, Ph.D.

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ei m Chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

SECTION 10

Indications for use statement

510(k) Number : K 03 28 74

Device Name: HBA Sperm-Hyaluronan Binding Assay

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.

Taylor
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03 2874