(145 days)
Not Found
Not Found
No
The summary describes a cell culture product for viral isolation and identification, with no mention of AI/ML, image processing, or data-driven algorithms. The performance study compares it to a pre-1976 predicate device, further indicating a traditional biological method.
No
The device is intended for the isolation and identification of viruses, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended for "isolation and identification of virus from clinical specimens," which directly points to a diagnostic purpose. The performance studies also mention "sensitivity to the inoculated viruses," further supporting its role in detecting and identifying pathogens.
No
The device description explicitly states "Expanded Primary Rhesus Monkey Kidney Cell Culture," which is a biological product, not software. The performance studies also describe testing with inoculated viruses, further indicating a biological or laboratory-based device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for use in the isolation and identification of virus from clinical specimens from patients having a viral infection." This involves testing biological samples (clinical specimens) outside of the body (in vitro) to diagnose or identify a condition (viral infection).
- Device Description: The device is a cell culture, which is a common tool used in laboratory settings for diagnostic purposes.
- Performance Studies: The performance studies describe testing the device's sensitivity to inoculated viruses, which is a typical evaluation for an IVD used in viral diagnostics.
- Predicate Device: The predicate device is also described as a "Primary Rhesus Monkey Kidney Cell Culture," further indicating its use in laboratory diagnostics.
The core function of the device, as described in the intended use, aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KIR
Device Description
RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)
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.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.2280 Cultured animal and human cells.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
0
KS71508
APPENDIX Ш page 1 of 1
SEP 1 7 1997 510(k) SUMMARY
BioWhittaker, Inc. 8830 Biggs Ford Road Walkersville, MD 21793 (301) 898-7025
Leif E. Olsen Contact: Vice President Regulatory Affairs
Deviče:
| Intended Use: | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| --------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
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
1
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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Page 2
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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) |