ADVIA TESTPOINT CSF CONTROL

K022968 · Bayer Diagnostics Corp. · JPK · Sep 24, 2002 · Hematology

Device Facts

• Record ID: K022968
• Device Name: ADVIA TESTPOINT CSF CONTROL
• Applicant: Bayer Diagnostics Corp.
• Product Code: JPK · Hematology
• Decision Date: Sep 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

ADVIA TESTpoint CSF Controls are hematology reference materials for monitoring the precision and accuracy of the ADVIA 120 Hematology System when analyzing CSF samples.

Device Story

ADVIA TESTpoint CSF Controls are assay control mixtures used for quality control of the ADVIA 120 Hematology System's CSF analysis method. The controls consist of human-derived red blood cells (RBC) and white blood cells (WBC) in a stabilizing medium. Two levels are provided: Level 1 (low cell count) and Level 2 (high abnormal cell count). The device is used in clinical laboratory settings by laboratory personnel to verify system performance. By analyzing these controls, clinicians monitor the precision and accuracy of the ADVIA 120 system, ensuring reliable reporting of RBC and WBC counts, as well as specific WBC differentials (Neut, Lymph, Mono, Eos, MN, PMN) for Level 2. This process helps maintain the integrity of patient CSF diagnostic results.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of stability testing demonstrating minimal variability (SD and %CV) and verification that the control materials meet manufacturer specifications for shelf life and open vial stability.

Technological Characteristics

Hematology reference material; human-derived RBCs and WBCs in stabilizing medium. Two-level configuration (low/high cell counts). Designed for automated analysis on the ADVIA 120 Hematology System. No electronic or software components; purely chemical/biological control material.

Indications for Use

Indicated for use as hematology reference materials to monitor precision and accuracy of the ADVIA 120 Hematology System during analysis of cerebrospinal fluid (CSF) samples.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Cell-Chex body fluid controls (K000076)

Submission Summary (Full Text)

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SEP 2 4 2002

# 510(k) Summary of Safety and Effectiveness

The following information provides data supporting a substantially equivalent determination for the ADVIA TESTpoint CSF Controls.

# Predicate Device

Cell-Chex body fluid controls manufactured by Streck Laboratories, Inc (K000076).

## Intended Use

ADVIA TEST ontrols are hematology reference materials for monitoring the precision and accuracy of the ADVIA 120 Hematology System when analyzing CSF samples.

## Device Description

ADVIA TESTpoint CSF Controls is an assay control mixture used for quality control of the ADVIA 120 CSF (cerebral spinal fluid) method. The control materials are composed of red blood cells and white blood cells derived from human sources stored in a stabilizing medium. The control materials consist of two levels that simulate a low cell count (Level 1) and a higher abnormal count (Level 2).

The following RBC and WBC parameters are reportable with the control materials:

Level 1 WBC - white blood cell count RBC - red blood cell count

Level 2

WBC - white blood cell count RBC - red blood cell count % Neut – percent neutrophil count % Lymph - percent lymphocyte count % Mono - percent monocyte count % Eos - percent eosinophil count % MN - percent mononuclear cell count % PMN - percent polymorphonuclear cell count

# Comparison with Predicate Device

The following table provides similarities and differences between ADVIA TESTpoint CSF Controls and the predicate device (K000076).

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| | | Predicate | ADVIA TESTpoint |
|--------------------------|-----------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Similarities/Differences | Characteristic | Device | CSF Controls |
| Similarities | Intended Use | Quality control material<br>for control of<br>cerebrospinal fluid cell<br>counts. | Same as predicate<br>device. |
| | Control<br>Composition | Human red blood cells<br>and human white blood<br>cells in a preservative<br>medium. | Similar to<br>predicate device. |
| | Targeted<br>Control Ranges | Level 1 – Low cell count<br>Level 2 - High abnormal<br>cell count | Similar to<br>predicate device. |
| Differences | Intended Use | Intended to control<br>manual cell counts. | Intended to control<br>ADVIA 120<br>automated cell<br>counts. |
| | Level 1 WBC<br>Differential | Two part WBC<br>Differential | No WBC<br>Differential on<br>Level 1 |
| | Level 2 WBC<br>Differential | Two part WBC<br>Differential | Five part WBC<br>Differential |

#### Conclusion

The test results included in this submission demonstrate that the ADVIA TEST point CSF Controls are substantially equivalent to the predicate device. The control materials have demonstrated acceptable precision as observed by the minimal variability (SD and %CV) found in stability testing, and meets the manufacturer's intended specifications for both shelf life and open vial stability.

Kuu-deff. Oks

Date 9/05/02

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511Benedict Avenue Tarrytown, New York 10591-5097

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 4 2002

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k022968

> Trade/Device Name: ADVIA TESTpoint CSF Controls Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: September 6, 2002 Received: September 6, 2002

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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#### K022968 510(k) Number:

Device Name: ADVIA TESTpoint CSF Controls

Indications for Use: ADVIA TESTpoint CSF Controls are hematology reference materials for monitoring the precision and accuracy of the ADVIA 120 Hematology System when analyzing CSF samples.

(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-CounterUse

(Optional Format 1-2-96)

Josephine Butler

Division Sign of Clinical Laborator 510(k) Number