(121 days)
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.
The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
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Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Lithium method, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicit pre-defined "acceptance criteria" in a go/no-go fashion. However, we can infer performance targets or expectations based on the predicate device's performance and the regression analysis.
| Performance Metric | Acceptance Criteria (Inferred/Predicate) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Total CV%) | Comparable to or better than predicate device (ThermoTrace) | |
| - Level ~1.00 - 1.15 mmol/L | ThermoTrace: 3.9% | 2.3% |
| - Level ~2.06 - 2.49 mmol/L | ThermoTrace: 3.6% | 1.8% |
| Correlation (with CDC Flame) | Strong correlation (R close to 1, small Syx) | R = 0.997, Syx = 0.06 mmol/L |
| Correlation (with ThermoTrace) | Strong correlation (R close to 1, small Syx) | R = 0.997, Syx = 0.05 mmol/L |
| Interference (Bilirubin unconjugated) | Clinically insignificant effect | 6% change at 30 mg/dL Bilirubin |
| Interference (Bilirubin conjugated) | Clinically insignificant effect | -2% change at 30 mg/dL Bilirubin |
| Interference (Hemoglobin) | Clinically insignificant effect | -2% change at 1000 mg/dL Hemoglobin |
| Interference (Lipids/Triglycerides) | Clinically insignificant effect | -9% change at 500 mg/dL Lipids |
| Analytical Range | Adequate for clinical use (e.g., matching predicate) | 0.10 - 3.00 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Correlation Studies: 49 samples (N=49) for both the comparison with CDC Flame and ThermoTrace systems.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a 510(k) submission, which typically involves internal validation testing by the manufacturer. Assuming typical practices, the samples were likely collected prospectively for the purpose of the study, and the origin is probably related to the manufacturer's testing facilities (e.g., within the US or a region where Bayer operates).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- None applicable. This is an in vitro diagnostic device for measuring a chemical analyte (Lithium). "Ground truth" for clinical decisions or image interpretation by experts is not relevant here. The ground truth for the comparison studies is established by reference methods or predicate devices (CDC Flame, ThermoTrace).
4. Adjudication Method for the Test Set:
- None applicable. As detailed in point 3, there are no "experts" in the sense of clinical decision-makers adjudicating results. The comparison methods act as the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant for this type of in vitro diagnostic device, which directly measures a chemical concentration rather than assisting human readers in interpreting complex diagnostic information (like medical images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The entire submission details the standalone performance of the ADVIA IMS Lithium method. The "device" is the algorithm/system for measuring lithium. There isn't a human-in-the-loop component in the measurement process itself, although a human interprets the numerical results for patient management. The data presented for imprecision, correlation, and interference are all standalone performance metrics.
7. The Type of Ground Truth Used:
- Reference Method/Predicate Device Measurements:
- For the correlation study with "Comparison System (X) CDC Flame," the ground truth for lithium concentration was established by the Centers for Disease Control (CDC) Flame Photometer, which is a recognized reference method.
- For the correlation study with "Comparison System (X) ThermoTrace," the ground truth was established by the predicate device, the ThermoTrace Lithium method.
- For imprecision and interference studies, the ground truth is often established by precise gravimetric or volumetric preparation of known concentrations, confirmed by a reference method.
8. The Sample Size for the Training Set:
- Not explicitly stated/not applicable in the same way as AI/ML. This device is a traditional immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the common sense for model development. The development process would involve method development, reagent formulation, and analytical validation rather than machine learning training.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As described above, this is a traditional in vitro diagnostic assay, not an AI/ML system requiring a training set with established ground truth labels for learning. The "ground truth" during development would be based on known chemical concentrations and performance against established analytical standards.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Lithium Method for ADVIA IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
Image /page/0/Picture/3 description: The image shows the text "The assigned 510(k) number is:" followed by the number K050374. The number is written in a large, bold font and is underlined. The text indicates that K050374 is a 510(k) number, which is a premarket submission made to the Food and Drug Administration (FDA) to demonstrate that the device to be marketed is safe and effective.
1. Intended Use
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.
2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| ThermoTrace Lithium | TR66056, TR66028 | TR66901 |
3. Device / Method
| Product Name | Reagent BAN # | Calibrator BAN # |
|---|---|---|
| ADVIA IMS Lithium | 00416019 | 06798711 |
A. Imprecision (serum)
| ADVIA IMS | ThermoTrace | ||
|---|---|---|---|
| Level(mmol/L) | TotalCV (%) | Level(mmol/L) | TotalCV(%) |
| 1.15 | 2.3 | 1.00 | 3.9 |
| 2.06 | 1.8 | 2.49 | 3.6 |
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| Specimen type | ComparisonSystem (X) | N | RegressionEquation | Syx(mmol/L) | R | SampleRange(mmol/L) |
|---|---|---|---|---|---|---|
| Serum | CDC Flame | 49 | Y=1.045X-0.06 | 0.06 | 0.997 | 0.3 - 2.8 |
| Serum | ThermoTrace | 49 | Y=1.116X-0.09 | 0.05 | 0.997 | 0.3 - 2.8 |
B. Correlation (Y=ADVIA IMS, X=Comparison system)
C. Interfering Substances
| InterferingSubstance | Interfering Sub.Conc. (mg/dL) | Lithium Conc.(mmol/L) | Effect(% change) |
|---|---|---|---|
| Bilirubin(unconjugated) | 30 | 1.08 | 6 |
| Bilirubin(conjugated) | 30 | 0.99 | -2 |
| Hemoglobin | 1000 | 1.12 | -2 |
| Lipids(Triglycerides) | 500 | 1.05 | -9 |
Analytical Range (serum/plasma): 0.10 - 3.00 mmol/L
Aran H. Zeller
2/9/2005
Date
Andres Holle Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
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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 consists of a stylized human figure with three arms or branches extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
JUN 1 5 2005
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Regulatory Affairs Bayer HealthCare LLC 511 Benedict Avenue Tarrytown, NY 10591
Re: K050374 Trade/Device Name: Lithium Assay for ADVIA IMS Assayed Chemistry Control 1 and Control 2 Chemistry Calibrator Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: NDW, JIX, JJY Dated: May 23, 2005 Received: May 25, 2005
Dear Mr. Holle:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
Image /page/4/Picture/1 description: The image shows the text '510(k) Number:' followed by the number 'K050374'. The text is written in a clear, legible font. The number appears to be a reference or identification code, possibly related to a regulatory submission or approval process.
Device Name: Lithium Assay for the ADVIA IMS
Indications for Use:
The Bayer ADV/A IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alata Sato
ਤੇ Page 1 of
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050374
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Indications for Use
510(k) Number (if known):_
Device Name: Assayed Chemistry Control 1 and Control 2
Indications For Use:
The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-On
Page 2 of 3
Office of In Vitro
Device Evaluation
510(K) K050374
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Indications for Use
510(k) Number (if known):_
Device Name: Chemistry Calibrator
Indications For Use:
The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Nllet Cutz
Division Sign-Out
Office of In Vitro Diagno Devine Evaluation and S
510ik, _
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§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.