(78 days)
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No
The summary describes a quantitative in vitro diagnostic method for measuring HDL Cholesterol, focusing on analytical performance metrics like imprecision, correlation, and interference. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No.
This device is an in vitro diagnostic method used to measure HDL Cholesterol for assessing cardiovascular risk, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma." It also mentions that these measurements are "used in the risk assessment of cardiovascular diseases."
No
The device is an in vitro diagnostic method intended to measure HDL Cholesterol in human serum and plasma using the Bayer ADVIA® IMS systems. This implies the use of physical laboratory equipment and reagents, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma..."
- "The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma."
These statements clearly indicate that the device is intended for use outside of a living organism (in vitro) to diagnose or aid in the diagnosis of a condition (assessing cardiovascular risk).
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.
The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.
Product codes (comma separated list FDA assigned to the subject device)
LBS
Device Description
ADVIA IMS Direct HDL Cholesterol
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Imprecision
| ADVIA IMS | ADVIA 1650 | ||
|---|---|---|---|
| Level mg/dL | Total CV (%) | Level mg/dL | Total CV(%) |
| 37.04 | 3.3 | 36.15 | 2.6 |
| 54.84 | 1.9 | 55.00 | 1.9 |
| 82.55 | 1.8 | 76.92 | 1.9 |
C. Correlation (Y=ADVIA IMS, X = Comparison system)
| Specimen type | Comparison
System (X) | N | Regression
Equation | Syx
mg/dL | R | IMS Sample
Range
mg/dL |
|---------------|--------------------------|-----|------------------------|--------------|-------|------------------------------|
| Serum | ADVIA 1650 | 100 | $Y=0.986X+1.16$ | 2.29 | 0.988 | 15 to 88 |
D. Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | HDL Cholesterol
Concentration
(mg/dL) | Effect
(% change) |
|-----------------------------|-----------------------------------|---------------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 30 | 44.3 | -1.1% |
| Bilirubin
(conjugated) | 20 | 46.5 | -7.3% |
| Hemoglobin | 500 | 46.2 | -9.5% |
| Lipids (Intralipid) | 1000 | 45.0 | -4.9% |
E. Analytical Range
7 to 90 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
MAY 2 6 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Direct HDL Cholesterol Method for ADVIA® Modular System (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.
The assigned 510(k) number is: Koso6 3 2
1. Intended Use
This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.
Predicate Device 2.
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Bayer ADVIA 1650 | 08058065 | 00309530 |
| Direct HDL Cholesterol | (B03-4763-01) |
Device / Method 3.
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| ADVIA IMS | 07986694 | 00309530 |
| Direct HDL Cholesterol | (B03-4763-01) |
Performance 4.
A. Imprecision
| ADVIA IMS | ADVIA 1650 | ||
|---|---|---|---|
| Level mg/dL | Total CV (%) | Level mg/dL | Total CV(%) |
| 37.04 | 3.3 | 36.15 | 2.6 |
| 54.84 | 1.9 | 55.00 | 1.9 |
| 82.55 | 1.8 | 76.92 | 1.9 |
C. Correlation (Y=ADVIA IMS, X = Comparison system)
| Specimen type | Comparison
System (X) | N | Regression
Equation | Syx
mg/dL | R | IMS Sample
Range
mg/dL |
|---------------|--------------------------|-----|------------------------|--------------|-------|------------------------------|
| Serum | ADVIA 1650 | 100 | $Y=0.986X+1.16$ | 2.29 | 0.988 | 15 to 88 |
1
D. Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | HDL Cholesterol
Concentration
(mg/dL) | Effect
(% change) |
|-----------------------------|-----------------------------------|---------------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 30 | 44.3 | -1.1% |
| Bilirubin
(conjugated) | 20 | 46.5 | -7.3% |
| Hemoglobin | 500 | 46.2 | -9.5% |
| Lipids (Intralipid) | 1000 | 45.0 | -4.9% |
E. Analytical Range
7 to 90 mg/dL.
Re h 3/4/2005
Date
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York, 10591 - 5097
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circular logo.
Public Health Service
Food and Drug Administrati 2098 Gaither Road Rockville MD 20850
MAY 2 6 2005
Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
Re: K050632
Trade/Device Name: Direct HDL Cholesterol for the ADVIA IMS Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: March 4, 2005 Received: March 9, 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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Page 2 -
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
4
Indications for Use
KOS 063 2 510(k) Number:
Device Name: Direct HDL Cholesterol for the ADVIA IMS
Indications for Use:
The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.
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)
Ruta Chester
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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KO50632 510(k)