The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

Device Description

The revised ADVIA 120 CSF method consists of the following changes to the ADVIA 120 Hematology System.

A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system.
Revised software to calculate the cell counts.
A software key to selectively allow access to the CSF mode of the system software.
Control products to maintain quality control of the CSF method.

The following parameters are reported with the ADVIA 120 CSF method:
White Blood Cell Parameters
WBC - white blood cell count
Neut - neutrophil count (percentage and absolute counts)
Lymph - lymphocyte count (percentage and absolute counts)
Mono - monocyte count (percentage and absolute counts)
Eos - eosinophil count (percentage and absolute counts)
MN - mononuclear count (percentage and absolute counts)
PMN -- polymorphonuclear count (percentage and absolute counts)
Red Blood Cell Parameters
RBC - red blood cell count

For Laboratory Use Only (not reportable)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the revised ADVIA 120 CSF method, based on the provided text:

Acceptance Criteria and Device Performance

The submission states that the revised ADVIA 120 CSF method "meets the manufacturer's intended specifications." However, specific numerical acceptance criteria were not explicitly provided in the given text. The comparison focuses on the methods of operation between the predicate and revised device, rather than quantitative performance targets. Therefore, the table below will reflect the characteristics of the method comparison described.

Acceptance Criteria (Implied by Comparison)	Reported Device Performance (Revised Method)
Intended Use	Same as predicate (quantitative determination of blood cells in CSF specimens)
Specimen Analyzed	Same as predicate (CSF collected in a sterile specimen tube)
WBC Count Method	Manual dilution with cell counts performed using RBC optics. RBCs are not lysed.
RBC Count Method	Manual dilution with cell counts performed using RBC optics.
WBC Differential Method	Manual dilution with cell performed using RBC optics. RBCs are not lysed, and WBCs are differentiated based on morphology only.

Study Details

The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with all the elements typically found in such a report. Many of the requested details are therefore not explicitly stated in this summary.

Here's what can be inferred or explicitly stated:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The abstract mentions "The test results included in this submission," implying internal testing by Bayer Corporation. There is no information about country of origin or whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given that this is a hematology analyzer, the ground truth would typically be established by manual microscopy by trained laboratory professionals (e.g., medical technologists or hematologists), but this is not explicitly stated.
Adjudication method:
- Not specified.
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 / Not done. This device is an automated hematology analyzer, not an AI diagnostic tool intended to assist human readers in image interpretation. The study evaluates the analyzer's performance directly, not human reader improvement.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. This is an automated device designed to operate in "standalone" mode, performing the cell counts and differentiations without human interpretation of raw data in the loop during the analysis process. The "manual open tube mode" refers to how the sample is introduced to the system, not that human interpretation is integrated into the result generation.
The type of ground truth used:
- Not explicitly stated in detail. For automated cell counters, the established ground truth is typically obtained through manual microscopy by skilled laboratory personnel using a hemocytometer for counts and stained slides for differentials. This is implied by the nature of the device but not directly stated.
The sample size for the training set:
- Not applicable / Not specified. This device is an automated system based on light scatter and absorbance measurements, not a machine learning model that requires a distinct "training set" in the common sense of AI/ML. The development likely involved internal validation and calibration with various samples, but these are not referred to as a "training set."
How the ground truth for the training set was established:
- Not applicable / Not specified. As noted above, there's no explicit mention of a "training set" in the context of an AI/ML model for which ground truth would be established for training purposes.

Summary

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SEP 1 1 2002

510(k) Summary of Safety and Effectiveness

The following information provides data supporting a substantially equivalent determination between the revised ADVIA 120 cerebrospinal fluid (CSF) method and the current ADVIA 120 CSF method (K003796).

Intended Use

Device Description

The revised ADVIA 120 CSF method consists of the following changes to the ADVIA 120 Hematology System.

1. A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system.
1. Revised software to calculate the cell counts.
1. A software key to selectively allow access to the CSF mode of the system software.
1. Control products to maintain quality control of the CSF method.

The following parameters are reported with the ADVIA 120 CSF method:

White Blood Cell Parameters

WBC - white blood cell count

Neut - neutrophil count (percentage and absolute counts)

Lymph - lymphocyte count (percentage and absolute counts)

Mono - monocyte count (percentage and absolute counts)

Eos - eosinophil count (percentage and absolute counts)

MN - mononuclear count (percentage and absolute counts)

PMN -- polymorphonuclear count (percentage and absolute counts)

Red Blood Cell Parameters

RBC - red blood cell count

For Laboratory Use Only (not reportable)

Principles of Operation

The CSF sample is mixed by manual dilution with ADVIA 120 CSF Reagent which isovolumetrically spheres and fixes the cells. After a 4-minute incubation period, the prepared sample is then aspirated directly into the ADVIA 120 system. The cells are then detected and enumerated based on light scatter and absorbance measurements using the ADVIA 120 laser optics. A scatter versus scatter versus absorbance cytogram is displayed with the thresholds and results automatically calculated for each sample

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Similarities and Differences between the revised ADVIA 120 CSF Method and the ADVIA 120 CSF Predicate Method (K003796)

The following table provides similarities and differences between the revised ADVIA 120 CSF method and the predicate method.

Similarities/Differences	Characteristic	PredicateMethod	RevisedMethod
Similarities	Intended Use	To provide aquantitativedetermination of bloodcells in CSFspecimens.	Same as predicatemethod.
	SpecimenAnalyzed	CSF collected in asterile specimen tube.	Same as predicatemethod.
Differences	WBC Count	Automated dilution withcell count performed inthe basophil channel ofthe ADVIA 120. RBCsare lysed in thereaction.	Manual dilutionwith cell countsperformed usingRBC optics. RBCsare not lysed.
	RBC Count	Automated dilution withcell count performed inRBC/PIt channel of theADVIA 120.	Manual dilutionwith cell countsperformed usingRBC optics.
	WBC Differential	Automated dilution withcell count performed inthe peroxidase channelof the ADVIA 120.RBCs are lysed andWBCs aredifferentiated based onmorphology andperoxidase activity.	Manual dilutionwith cell performedusing RBC optics.RBCs are notlysed, and WBCsare differentiatedbased onmorphology only.

Conclusion

The test results included in this submission demonstrate that the revised ADVIA 120 CSF method meets the manufacturer's intended specifications and is substantially equivalent to the predicate device.

Kluwe E.D. Cole

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

Date

7/16/02

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

od and Drug Administ 98 Gaither Road ockville MD 20850

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

K022331 Re:

Trade/Device Name: Cerebrospinal Fluid Method for the Advia 120 Hematology Analyzer Regulation Number: 21 CFR § 864.5200 Regulation Name: Automated cell counter Regulatory Class: II Product Code: GKL, GKZ, JPK Dated: August 28, 2002 Received: August 29, 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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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" (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 Putman

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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11022331 510(k) Number:

Device Name: Cerebrospinal Fluid Method for the Advia 120 Hematology Analyzer

Indications for Use: The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K022331

Prescription Use (Per 21 CFR 801.109)		OR	Over-The-CounterUse
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(Optional Format 1-2-96)

Regulation Number and Section

§ 864.5200 Automated cell counter.

(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).