ALLGRAD 45 AND 90 CELL SEPARATION MEDIA

K022330 · <Genx> Intl., Inc. · MQL · Aug 26, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022330
• Device Name: ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
• Applicant: <Genx> Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AllGrad 45 and 90 cell separation media by <genX> is intended for use in assisted reproduction techniques.

Device Story

AllGrad 45 and 90 are density gradient solutions used in assisted reproduction techniques (ART). The device facilitates the separation of cells, typically sperm, based on density. It is used in clinical laboratory settings by embryologists or trained laboratory personnel. The media is prepared as a gradient to isolate motile, morphologically normal sperm from seminal fluid, debris, and non-motile cells. By providing a purified sperm population, the device assists in procedures such as intrauterine insemination (IUI) or in vitro fertilization (IVF), potentially improving fertilization outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Density gradient solution for cell separation. Consists of chemical media formulated for reproductive applications. Class II device under 21 CFR 884.6180.

Indications for Use

Indicated for use in assisted reproduction techniques for cell separation.

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Submission Summary (Full Text)

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od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**AUG 26 2002**

Mr. Michael D. Cecchi President <genX> International, Inc. 393 Soundview Rd. GUILFORD CT 06437

Re: K022330

Trade/Device Name: Allgrad™ 45 and 90 Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements

Regulatory Class: II Product Code: 85 MQL Dated: July 15, 2002 Received: July 18, 2002

Dear Mr. Cecchi:

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 either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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<genX>international, inc. 510(K) Submission

## INDICATIONS FOR USE

510 (k) Number (if known)_____________________________________________________________________________________________________________________________________________________

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K022330

Device Names: ALLGrad™ Cell Separation Media 45% and 90% Density Gradient Solution

Indication for Use:

AllGrad 45 and 90 cell separation media by <genX> is intended for use in assisted reproduction techniques.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <u>/</u> or | Over-the Counter Use ______ |
|------------------------------|-----------------------------|
|------------------------------|-----------------------------|

*Nancy Brogdon*
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K022330 |
|---------------|---------|
|---------------|---------|

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