(63 days)
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: Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV; Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV; Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups; HSV, CMV; Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps; Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella; 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.
The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, 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 after a short pre-incubation period.
The provided K773414 510(k) summary describes the submission for "FreshCells™," which are cultured cells intended for use as hosts for the isolation and identification of specific viruses. This document establishes substantial equivalence to a predicate device and focuses on the characterization and performance of these cell lines.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Source of Cell Line | ATCC or another approved supplier. | Same as predicate device (ATCC or approved supplier). |
| Provided as nearly confluent monolayers | Cells are provided routinely as nearly confluent monolayers. | Same as predicate device (nearly confluent monolayers). |
| Intended Use | Isolation & Confirmation of specific viruses. | Same as predicate device (Isolation & Confirmation of specific viruses). |
| Growth Characteristics | (Implied: Normal and robust growth for cell culture applications) | Characterized (Non-clinical tests performed). |
| Sterility | (Implied: Sterile for cell culture applications) | Characterized (Non-clinical tests performed). |
| Isoenzyme Analysis | (Implied: Consistent and appropriate isoenzyme profiles) | Characterized (Non-clinical tests performed). |
| Virus Susceptibility (Cell Line/Virus Specific) | Predicate device demonstrated susceptibility to viruses relevant to its intended use. | Subject device demonstrated susceptibility to a list of specific viruses for each proposed cell line (HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero, WI-38). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an algorithm or diagnostic model. The evaluation here is for cell cultures. The "testing" refers to the characterization and virus susceptibility studies performed on the subject FreshCells™ lines.
- Sample Size: Not explicitly stated in terms of a numerical count for a test set. This refers to the batches of cells produced and tested during characterization and virus susceptibility studies.
- Data Provenance: The studies were performed by Diagnostic Hybrids, Inc. The data would be prospective in the sense that the characterization and susceptibility testing were performed on newly produced batches of FreshCells™ as part of the validation process. The country of origin is implicitly the United States, where Diagnostic Hybrids, Inc. is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission. "Ground truth" in this context is established through standard laboratory methods for cell culture characterization and virology testing (e.g., observing cytopathic effect, immunofluorescence, PCR, etc., which are common laboratory techniques). There is no mention of human experts establishing a subjective "ground truth" for a test set in the way one might for image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process as there would be for subjective interpretations (e.g., imaging reads). The results of cell culture characterization and virus susceptibility testing are typically determined by objective laboratory assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for cultured cells, not an AI-powered diagnostic device or an imaging system that would involve human "readers" or an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The Type of Ground Truth Used
The "ground truth" for this device, which refers to the expected biological behavior and characteristics of the cell lines, is established through:
- Standard Laboratory Assays: This includes macroscopic and microscopic observation of cell growth, morphology, sterility testing, and isoenzyme analysis (to confirm cell line identity).
- Established Virology Protocols: For virus susceptibility, the ground truth is whether a specific cell line reliably supports the replication and identification of a given virus, which is determined by inoculating the cells with known viral strains and observing cytopathic effects or other established detection methods. This is based on decades of virology research and established scientific literature on viral tropism.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI or machine learning device, there is no "training set" in the conventional sense. The development of the FreshCells™ lines relies on established cell culture techniques and knowledge from continuously maintaining and characterizing these cell lines over time.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an algorithm. The "knowledge base" for developing and characterizing these cell lines comes from:
- Scientific Literature and ATCC standards: Established characteristics and maintenance protocols for cell lines obtained from sources like ATCC.
- Internal Quality Control Data: Ongoing in-house testing and characterization of cell batches over their production history to ensure consistency and meet specifications. The submission mentions "non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility," which collectively form the basis of the "ground truth" for these cell lines.
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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, BKpolyomavirus, Reoviruses, Measles virus,RSV, some strains of Influenza type A, mostEnteroviruses and Rhinoviruses, Parainfluenzaand 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 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 providedroutinely as nearlyconfluent monolayers. | Same as predicate device. |
| Intended Use. | Isolation & Confirmationof 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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 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
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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.
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(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
§ 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.