FRESH CELLS LLC-MK2

K973213 · Diagnostic Hybrids, Inc. · KIR · Sep 25, 1997 · Hematology

Device Facts

• Record ID: K973213
• Device Name: FRESH CELLS LLC-MK2
• Applicant: Diagnostic Hybrids, Inc.
• Product Code: KIR · Hematology
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.2280
• Device Class: Class 1

Indications for Use

Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: [Table of cell lines and viruses omitted for brevity]. FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

Device Story

FreshCells™ consist of cultured animal and human cell lines (HEL, HFF, LLC-MK2, Mv1Lu, NCI-H292, Vero, WI-38) provided as nearly confluent monolayers in multiwell plates, shell vials, or tubes. Used in clinical laboratories as host systems for isolating and identifying viruses and Chlamydia from patient clinical samples. Laboratory technicians inoculate cell cultures with clinical specimens; viral/chlamydial growth is monitored to confirm presence of specific pathogens. Provides standardized host environment for diagnostic confirmation; facilitates clinical decision-making regarding antiviral treatment.

Clinical Evidence

No clinical data. Product characterization performed via non-clinical bench testing, including appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility testing.

Technological Characteristics

Cultured human and animal cell lines (HEL, HFF, LLC-MK2, Mv1Lu, NCI-H292, Vero, WI-38). Provided as nearly confluent monolayers in multiwell plates, shell vials, or tubes. Biological product; no electronic or mechanical components.

Indications for Use

Indicated for isolation and identification of viruses and Chlamydia from clinical specimens in patients, including immunocompromised individuals, where viral identification is required for clinical management and antiviral therapy.

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

• BioWhittaker cell cultures (unspecified 510(k))
• FreshCells™ (K936271)
• FreshCells™ (K962306)

Submission Summary (Full Text)

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915613

510 (k) Summary

- Diagnostic Hybrids, Inc. a.1. 1 President Street Athens, OH 45701 [phone] FAX: [phone] Attn: J.L. Brown Date of Preparation: June 10, 1997
- Trade Name: FreshCells™ a.2. Cells, Animal and Human, Cultured. Classification Name:
- A predicate device is that of BioWhittaker, marketed as cell cultures, a.3. Appendix II, pp. A-11 to A-13 of this 510(k), Notification.
- The subject device provides HEL, HFF, LLC-MK2, MV1Lu, NCI H292, Vero and a.4. The Subject devise proon to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt a short pre-incubation period. after
- Intended Use: Cell cultures to be used as hosts for the isolation and a.5. identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:

| CELL LINE/ORIGIN | SPECIFIC VIRUSES |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV. |
| HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV. |
| LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups. |
| Mv1Lu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco-<br>epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps. |
| Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella |
| WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV. |

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## a.6. A comparison of Technological Characteristics:

| Characteristics | Predicate Device | Subject Device |
|-----------------------------------------------|--------------------------------------------------------------------|---------------------------|
| Source of Cell Line. | ATCC or another approved supplier. | Same as predicate device. |
| Provided as nearly con-<br>fluent monolayers. | Cells are provided<br>routinely as nearly<br>confluent monolayers. | Same as predicate device. |
| Intended Use. | Isolation & Confirmation<br>of specific viruses. | Same as predicate device. |

- The non-clinical tests consist of those used to characterize the product b.l. such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
- b.2. Not applicable.
- b.3. Not applicable.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

James L. Brown Vice President Product Development and · Regulatory Affairs Diagnostic Hybrids, Inc. One President Street Athens, Ohio 45701

SEP 2 5 1997

Re: K973213 Trade Name: Fresh Cells™ LLC-MK, Regulatory Class: I Product Code: KIR Dated: August 22, 1997 Received: August 27, 1997

Dear Mr. Brown:

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 QS 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 Sutman

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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## Indications for Use Statement

510 (k) Number (if known) :

FreahCella™ in Multiwell Plates, Shell Vials and Tubes. Device Name:

FreshCells™ are indicated for use in the isolation of Indications for Use: various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

Cen Poin

Division 973213 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________