(29 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, 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: 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.
FreshCella™ 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 Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided 510(k) summary for K973211 describes the "FreshCells™" product, which consists of various cell lines intended for the isolation and identification of specific viruses. However, the document does not present a typical device performance study with quantitative acceptance criteria as might be seen for a diagnostic test with metrics like sensitivity or specificity.
Instead, the acceptance criteria are implicitly defined by a comparison to a predicate device and a demonstration of the cell lines' suitability for their intended use through characterization tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are performance characteristics, and the device performance is stated as being "Same as predicate device" for these characteristics.
| Acceptance Criteria (Characteristic) | Reported Device Performance (Subject Device) |
|---|---|
| Source of Cell Line | ATCC or another approved supplier (Same as predicate device) |
| Provided as nearly confluent monolayers | Cells are provided routinely as nearly confluent monolayers (Same as predicate device) |
| Intended Use | Isolation & Confirmation of specific viruses (Same as predicate device) |
| Susceptibility to Specific Viruses | Refer to Table 1: Cell Line Susceptibility to Viruses below, demonstrating susceptibility for the listed viruses. |
| Appearance | Characterized (Non-clinical tests performed) |
| Growth characteristics | Characterized (Non-clinical tests performed) |
| Sterility | Characterized (Non-clinical tests performed) |
| Isoenzyme analysis | Characterized (Non-clinical tests performed) |
| Virus susceptibility | Characterized (Non-clinical tests performed), and demonstrated for specific viruses |
Table 1: Cell Line Susceptibility to Viruses (Part of Device Performance demonstrating acceptance of virus susceptibility)
| 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. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in terms of clinical samples with a defined sample size. The testing appears to be primarily laboratory-based characterization of the cell lines themselves. Therefore, information on data provenance (country of origin, retrospective/prospective) is not provided and not applicable in the context of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The "ground truth" for cell line characteristics is established through standard laboratory assays and adherence to established cell culture practices (e.g., verifying sterility, growth rates, isoenzyme analysis). The "ground truth" for virus susceptibility is based on the known tropism of viruses for specific cell lines, which is part of general scientific knowledge in virology and cell biology, rather than being established by a panel of experts for a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a human expert adjudication process for a test set in the context of the device's assessment.
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 device is a biological reagent (cell culture) and not an AI-powered diagnostic system. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a biological reagent (cell culture) and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance, i.e., the proper functionality of the cell lines, is based on:
- Laboratory Characterization: Demonstrating expected appearance, growth characteristics, sterility, and isoenzyme analysis according to established scientific and quality control standards for cell cultures.
- Established Viral Tropism: The susceptibility of the cell lines to specific viruses is based on well-known scientific literature and established laboratory practices in virology.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
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510 (k) Summary
SEP 2 5 Incr
- Diagnostic Hybrids, Inc. a.l. 1 President Street Athens, OH 45701 (614) 593-1784 FAX: (614) 593-0980 Attn: J.L. Brown June 10, 1997 Date of Preparation:
- 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. 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 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-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.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-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. ric nor crinedi belo below of enere assure and to be
such as appearance, growth characteristics, sterility, isoenzyme
analysis and virus susceptibility.
b.2. Not applicable.
b.3. Not applicable.
:
.. .
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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
SEP 2 5 1997
Re: K973211 Trade Name: Fresh Cells™ Mv1Lu 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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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 Gutman
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):
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FreshCelland in Multiwell Plates, Shell Vials and Tubes. Device Name:
FreshCella™ 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.
Ole P
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
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.