(63 days)
No
The 510(k) summary describes cell cultures for viral isolation and identification. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on the biological characteristics of the cell lines.
No
The device provides cell cultures for the isolation and identification of viruses and Chlamydia, which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use explicitly states that the cell cultures are "for the isolation and identification of specific viruses" and "can be used in the isolation and confirmation of the following viruses from clinical samples." This indicates the device is used to diagnose the presence of viruses.
No
The device description clearly states that the device provides cell lines as nearly confluent monolayers, which are physical biological materials, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the cell cultures are "to be used as hosts for the isolation and identification of specific viruses" from "clinical samples." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device provides cell lines as "nearly confluent monolayers ready for use upon receipt." These cells are the medium for performing the diagnostic test (virus isolation and identification).
- Performance Studies: The summary of performance studies mentions "virus susceptibility," which is a key characteristic evaluated for an IVD used in virology.
The core function of this device is to facilitate the isolation and identification of viruses from clinical samples, which is a diagnostic process performed outside of the human body (in vitro).
N/A
Intended Use / 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, Mv1Lu, 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 mucoepidermoid 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. |
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens.
Product codes
KIR
Device Description
The subject device provides HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 cells (in addition 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 Cells™) as nearly confluent monolayers ready for use upon receipt a short pre-incubation period. after
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
Not Found
Summary of Performance Studies
The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
Key Metrics
Not Found
Predicate Device(s)
BioWhittaker cell cultures
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510 (k) Summary
Diagnostic Hybrids, Inc. a.1. 1 President Street Athens, OH 45701 (614) 593-1784 FAX: (614) 593-0980 Attn: J.L. Brown Date of Preparation: June 10, 1997
AUG 2 9 1997
- Trade Name: FreshCells™ a.2. Classification Name: Cells, Animal and Human, Cultured.
- 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, MvlLu, NCI H292, Vero and a.4. WI-38 cells (in addition 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 Cells™) 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, Mv1Lu, 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- | |
| 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. |
1
A comparison of Technological Characteristics: a.6.
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Source of Cell Line. | ATCC or another approved supplier. | Same as predicate device. |
| Provided as nearly con- | ||
| fluent monolayers. | Cells are provided | |
| routinely as nearly | ||
| confluent monolayers. | Same as predicate device. | |
| Intended Use. | Isolation & Confirmation | |
| of specific viruses. | Same as predicate device. |
- The non-clinical tests consist of those used to characterize the product b.1. such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
b.2. Not applicable.
Not applicable. b.3.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on one line. The text appears to be extracted from a document or sign.
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
AUG 2 9 1997
Re: K972414 Trade Name: FreshCells Regulatory Class: I Product Code: KIR Dated: June 24, 1997 Received: June 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 (OS) 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.
3
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 vours.
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
4
Indications for Use Statement
510 (k) Number (if known) : _
Device Name: FreshCells™ in Multiwell Plates, Shell Vials and Tubes.
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 They cause a variety of diseases in man with some virus cellular hosts. 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.
P^
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972414
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use