FRESH CELLS NCI H292

• K Number: K973210
• Device Name: FRESH CELLS NCI H292
• Manufacturer: DIAGNOSTIC HYBRIDS, INC.
• Date Cleared: 1997-09-25 ( 29 days)
• Product Code: KIR
• Regulation Number: 864.2280
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: K936271 , K962306

Intended Use

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 Description

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.

AI/ML Overview

This document is a 510(k) summary for a medical device called FreshCells™ by Diagnostic Hybrids, Inc. This device provides various cultured cell lines (HEL, HFF, LLC-MK2, MV1Lu, NCI/H292, Vero, and WI-38) to be used as hosts for the isolation and identification of specific viruses.

Here's an breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance:

The document describes the device's characteristics and compares them to a predicate device. The acceptance criteria are implicitly defined by the substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

   Characteristics	Acceptance Criteria (Predicate Device)	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.
   Specific Viruses Susceptibility (Cell Line dependent)	(Not explicitly listed as a single table here but detailed for each predicate cell line in the "Intended Use" section for FreshCells™. The subject device must demonstrate susceptibility to these viruses.)	The subject device cell lines (HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero, and WI-38) are explicitly stated to be "susceptible to and can be used in the isolation and confirmation of" the respective viruses listed in the Intended Use table.

2. Sample Size Used for the Test Set and the Data Provenance:

   • The document implies that non-clinical tests were performed to characterize the product (appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility). However, specific sample sizes for these tests are not provided.
   • Data Provenance: Not explicitly stated. The tests are referred to as "non-clinical tests" conducted to characterize the product.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • Not applicable. The provided text does not describe a study involving human readers or experts establishing ground truth for evaluating the device's diagnostic performance against a reference standard in a clinical setting. This device is a tool (cell culture) used by laboratory personnel, not a diagnostic algorithm that analyzes data and requires expert ground truth for its output.

4. Adjudication Method for the Test Set:

   • Not applicable. See point 3.

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 cell culture medium, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. See point 5. This device is a biological product used in a laboratory process; it is not an algorithm.

7. The Type of Ground Truth Used:

   • For the performance related to virus susceptibility, the "ground truth" would be the demonstrated ability of the cell lines to successfully isolate and confirm the presence of the specified viruses based on established laboratory protocols. This is typically achieved through experimental validation and literature references for viral tropism in specific cell lines.

8. The Sample Size for the Training Set:

   • Not applicable. This device is a biological product used for culturing, not a machine learning model that requires a "training set." The development of the cell lines and characterization would involve various analytical and biological assays, but not in the context of a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established:

   • Not applicable. See point 8.

Regulation Number and Section

§ 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.