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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the ADVIA TESTpoint CSF Controls, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document directly states the acceptance criterion in the conclusion: "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."

However, the specific numerical thresholds for "minimal variability" (SD and %CV) and the "manufacturer's intended specifications" for shelf life and open vial stability are not explicitly provided in the given text. Without these direct numerical targets, a table showing a comparison isn't fully possible.

Table 1: Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance
Precision (Variability)	Minimal variability (SD and %CV) – Specific numerical thresholds not provided	"Acceptable precision as observed by the minimal variability (SD and %CV) found in stability testing."
Shelf Life Stability	Manufacturer's intended specifications – Specific duration and stability metrics not provided	"Meets the manufacturer's intended specifications for both shelf life..."
Open Vial Stability	Manufacturer's intended specifications – Specific duration and stability metrics not provided	"...and open vial stability."

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

Sample Size: The document does not explicitly state the sample size used for the "test set." It mentions "stability testing" but does not quantify the number of runs, samples, or trials.
Data Provenance: The data appears to be prospective as it involves "stability testing" which is typically conducted to generate performance data over time. No information is provided regarding the country of origin of the data.

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

This information is not applicable and not provided for this device. The ADVIA TESTpoint CSF Controls are hematology reference materials, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. Their "ground truth" is their precisely measured and stable composition, which is verified through laboratory testing.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided for this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation of diagnostic results to resolve discrepancies. As discussed above, this device does not involve such human interpretation for its performance evaluation.

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:

This information is not applicable and not provided. This device is a quality control material for an automated hematology system (ADVIA 120). It is not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its purpose.

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

This information is not applicable. The device itself is a control material, not an "algorithm." Its performance is evaluated through its stability and ability to provide consistent results when run on the ADVIA 120 system. The "study" here is essentially the stability testing of the control material itself, and its consistency when used with the automated analyzer.

7. The Type of Ground Truth Used:

The "ground truth" for the ADVIA TESTpoint CSF Controls is established by the inherent, precisely manufactured composition of the control materials (red blood cells and white blood cells in a stabilizing medium) and their intended target ranges. The validation study (stability testing) verifies that this manufactured "ground truth" remains stable over time and across different conditions (e.g., open vial). It is not pathology, outcomes data, or expert consensus in the typical sense for a diagnostic test.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm that requires a "training set." Its development involves formulation, manufacturing, and stability testing, not algorithmic training.

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

This information is not applicable and not provided for the same reasons as in point 8.

Summary

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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

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 materialfor control ofcerebrospinal fluid cellcounts.	Same as predicatedevice.
	ControlComposition	Human red blood cellsand human white bloodcells in a preservativemedium.	Similar topredicate device.
	TargetedControl Ranges	Level 1 – Low cell countLevel 2 - High abnormalcell count	Similar topredicate device.
Differences	Intended Use	Intended to controlmanual cell counts.	Intended to controlADVIA 120automated cellcounts.
	Level 1 WBCDifferential	Two part WBCDifferential	No WBCDifferential onLevel 1
	Level 2 WBCDifferential	Two part WBCDifferential	Five part WBCDifferential

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 (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" (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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1

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)

Over-The-CounterUse

(Optional Format 1-2-96)

Josephine Butler

Division Sign of Clinical Laborator 510(k) Number

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
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).(b)
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.