RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE

K971508 · Bio-Whittaker, Inc., A Cambrex Co. · KIR · Sep 17, 1997 · Hematology

Device Facts

• Record ID: K971508
• Device Name: RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
• Applicant: Bio-Whittaker, Inc., A Cambrex Co.
• Product Code: KIR · Hematology
• Decision Date: Sep 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.2280
• Device Class: Class 1

Indications for Use

RHMK II is intended for use in the isolation and identification of virus RHMK II is intended for use in the footation and teach of having a viral infection.

Device Story

RhMK II (Expanded Primary Rhesus Monkey Kidney Cell Culture) serves as a host system for viral cultivation. Clinical specimens are inoculated into cell cultures; cultures are incubated and observed for viral replication. Detection methods include monitoring for cytopathic effect (CPE), hemadsorption, or staining with virus-specific fluorescent antibody markers. Used in clinical laboratory settings by trained personnel to identify viral presence in patient samples. Provides a higher cell yield compared to traditional primary cultures, reducing animal usage requirements.

Clinical Evidence

Bench testing only. Infectivity comparison study performed between the subject RhMK II and the predicate Primary Rhesus Monkey Kidney Cell Culture. Results demonstrated similar sensitivity for the isolation of polio 1, coxsackie B1, influenza A, parainfluenza 2, measles, and mumps.

Technological Characteristics

Expanded Primary Rhesus Monkey Kidney Cell Culture. Biological cell culture system for viral isolation. Does not utilize electronic, mechanical, or software-based components.

Indications for Use

Indicated for the isolation and identification of viruses in patients suspected of having a viral infection.

Regulatory Classification

Identification

Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

Predicate Devices

• Primary Rhesus Monkey Kidney Cell Culture (pre-1976 device)

Submission Summary (Full Text)

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KS71508

APPENDIX Ш page 1 of 1

SEP 1 7 1997 510(k) SUMMARY

BioWhittaker, Inc. 8830 Biggs Ford Road Walkersville, MD 21793 [phone]

Leif E. Olsen Contact: Vice President Regulatory Affairs

## Deviče:

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Device Function:

Device Performance:

RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)

BioWhittaker's RhMK II is intended to be used as an alternative to the use of Primary Rhesus Monkey Kidney Cell Culture. Use of these cells increases the yield possible from each kidney and reduces the number of animals required to satisfy cell requirements.

Cultures of live cells are the most convenient host system for the cultivation of viruses. After inoculation of the culture with a clinical specimen and incubation, the culture is observed for evidence of viral replication. Infection by virus can result in the development of characteristic cytopathic effect (CPE) and / or hemadsorption, or staining with specific virus fluorescent antibody markers.

Infectivity comparison testing between BioWhittaker's Primary Rhesus Monkey Kidney Cell Culture (a pre-1976 device) and RhMK II, an expanded Primary Rhesus Monkey Kidney Cell Culture demonstrates similar sensitivity to the inoculated viruses polio 1, coxsackie B1, influenza A, parainfluenza 2, measles and mumps.

Conclusion: BioWhittaker's RhMK II is safe and effective, performing as well as the currently available Primary Rhesus Monkey Kidney Cell Culture for viral isolation in clinical specimens.

Preparation Date:

April 22, 1997

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 7 1997

Leif E. Olsen Vice President Regulatory Affairs · Bio-Whittaker, Inc. 8830 Biggs Ford Road Walkersville, Maryland 21793-0127

Re: K971508 Trade Name: RhMK II Cell Culture Regulatory Class: I Product Code: KIR Dated: July 15, 1997 Received: July 16, 1997

Dear Mr. Olsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 and additionally 809.10 for in-vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 _of_1

510(k) Number (if known):____ K971508

Device Name: RHMK II Cell Culture

Indications For Use:

ﺎ" ﻫﺮ

RHMK II is intended for use in the isolation and identification of virus RHMK II is intended for use in the footation and teach of having a viral infection.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | for AFP |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971508 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |