FRESHCELLS, HEP-2

K962780 · Diagnostic Hybrids, Inc. · KIR · Aug 29, 1996 · Hematology

Device Facts

• Record ID: K962780
• Device Name: FRESHCELLS, HEP-2
• Applicant: Diagnostic Hybrids, Inc.
• Product Code: KIR · Hematology
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.2280
• Device Class: Class 1

Indications for Use

Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus Parainfluenza HSV Poliovirus Coxsackie B RSV Measles

Device Story

FreshCells™ HEp-2 cell line provided as nearly confluent monolayers; used by laboratory personnel for virus isolation and identification from clinical samples. Cells serve as host for viral propagation; viral presence confirmed via standard laboratory methods. Product facilitates diagnostic confirmation of specific viral pathogens; supports clinical decision-making regarding viral infection management.

Clinical Evidence

Bench testing only; includes product characterization via appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility testing.

Technological Characteristics

HEp-2 cell line; provided as nearly confluent monolayers; sourced from ATCC or approved supplier.

Indications for Use

Indicated for use in the isolation and confirmation of Adenovirus, Parainfluenza, HSV, Poliovirus, Coxsackie B, RSV, and Measles from clinical samples.

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

Submission Summary (Full Text)

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K962780

# AUG 29 1996

# 510(k) Summary

a.1. Diagnostic Hybrids, Inc.
1 President Street
Athens, OH 45701
[phone]
FAX: [phone]
Attn: J.L. Brown
Date of Preparation: July 12, 1996

a.2. Trade Name: FreshCells™
Classification Name: Cells, Animal and Human, Cultured.

a.3. A predicate device is that of BioWhittaker, marketed as cell cultures, Appendix II, p.19 of this 510(k) Notification.

a.4. The subject device provides HEp-2 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

a.5. Intended Use: Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:

Adenovirus
Parainfluenza
HSV
Poliovirus
Coxsackie B
RSV
Measles

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 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. |

b.1. The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.

b.2. Not applicable.

b.3. Not applicable.