(55 days)
Not Found
No
The description focuses on reagent reformulation and revised software for calculation, with no mention of AI/ML terms or concepts.
No
The device is an in vitro diagnostic device used to quantify blood cells in CSF specimens. It provides diagnostic information and does not treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens."
No
The device description explicitly states that the revised method includes a reformulated reagent and control products, which are physical components, in addition to software changes. This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended to "provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens." The term "in vitro diagnostic" is a direct indicator.
- Specimen Type: The device analyzes "CSF specimens," which are biological samples taken from the human body. This is characteristic of IVD devices.
- Analysis Location: The analysis is performed "in the manual open tube mode," implying the analysis is done outside of the living organism (in vitro).
- Parameters Measured: The device measures blood cell parameters (WBC, RBC, and differential counts) in the CSF. These are diagnostic markers used to assess a patient's health status.
- Care Setting: The device is intended for "Laboratory Use Only," which is a common setting for IVD testing.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GKL, GKZ, JPK
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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)
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
1
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 | Predicate
Method | Revised
Method |
|--------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | Intended Use | To provide a
quantitative
determination of blood
cells in CSF
specimens. | Same as predicate
method. |
| | Specimen
Analyzed | CSF collected in a
sterile specimen tube. | Same as predicate
method. |
| Differences | WBC Count | Automated dilution with
cell count performed in
the basophil channel of
the ADVIA 120. RBCs
are lysed in the
reaction. | Manual dilution
with cell counts
performed using
RBC optics. RBCs
are not lysed. |
| | RBC Count | Automated dilution with
cell count performed in
RBC/PIt channel of the
ADVIA 120. | Manual dilution
with cell counts
performed using
RBC optics. |
| | WBC Differential | Automated dilution with
cell count performed in
the peroxidase channel
of the ADVIA 120.
RBCs are lysed and
WBCs are
differentiated based on
morphology and
peroxidase activity. | Manual dilution
with cell performed
using RBC optics.
RBCs are not
lysed, and WBCs
are differentiated
based on
morphology 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
2
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.
3
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
4
Page 1 of 1
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)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K022331 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-CounterUse | |
|---|---|---|---|
| --------------------------------------- | ------------- | ---- | --------------------- |
(Optional Format 1-2-96)
(Optional Format 1-2-96)