LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA

K083509 · Genx Intl., Inc. · MQL · Apr 24, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K083509
• Device Name: LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
• Applicant: Genx Intl., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Apr 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

LifeGlobal® Human Serum Albumin (HSA) is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

Device Story

LifeGlobal Human Serum Albumin (HSA) is a protein supplement used in assisted reproductive technology (ART) procedures. It is added to culture media to support in vitro fertilization, embryo culture, and cryopreservation. The device is used in clinical laboratory settings by embryologists or trained laboratory personnel. By providing necessary protein supplementation, it helps maintain optimal conditions for embryo development and survival during ART processes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human Serum Albumin (HSA) solution for protein supplementation in reproductive media. Class II device (21 CFR 884.6180, Product Code MQL).

Indications for Use

Indicated for use in assisted reproductive procedures requiring protein supplementation, including in vitro fertilization, embryo culture, and embryo cryopreservation.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 4 2009

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

Re: K083509

Trade/Device Name: LifeGlobal® Human Serum Albumin LG HSA Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: April 17, 2009 Received: April 21, 2009

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.

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); medical device reporting (reporting of medical device-related adverse, events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

[signature]

Janine M. Morris Acting 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.

B

INDICATIONS FOR USE

Ko 83509 510 (k) Number (if known)

Device Name: LifeGlobal ® Human Serum Albumin LG HSA

Indications for Use:

LifeGlobal ® Human Serum Albumin (HSA) is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use *X* or

Over-the Counter Use

Arijit Khan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number _