(45 days)
Not Found
No
The document describes a calibrator solution for laboratory assays, with no mention of AI or ML technology.
No
The device is described as an in vitro diagnostic calibrator, used to calibrate assays, not to treat a condition.
Yes
The document explicitly states, "The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use."
No
The device description explicitly states it is a "human serum based solution containing various non human and human constituents," indicating it is a physical calibrator, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use..."
This statement, along with the description of the device as a calibrator for assays performed on chemistry systems, clearly indicates its purpose is for use in laboratory settings to diagnose or monitor conditions based on analysis of biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1, Apolipoprotein B assays and Direct HDL on the ADVIA IMS Chemistry systems.
Product codes (comma separated list FDA assigned to the subject device)
75 JIX
Device Description
The Lipoprotein Calibrator is a human serum based solution containing various non human and human constituents.
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
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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)
The stability of the Lipoprotein calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use.
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.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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AUG 1 - 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Lipoprotein Calibrator
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:
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Submitter's name, address and telephone number:
Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC A subsidiary of Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591 TEL: 914-524-3494 FAX: 914-524-2500 Email: andres.holle.b@bayer.com
2. Name of the device:
| a) Classification Names: | Calibrator, §862.1150 | |
|---|---|---|
| Classification: | Class II | |
| Product Code: | 75 JIX |
- b) Common name: Calibrator for multiple assays
- c) Proprietary name: Lipoprotein Calibrator
- d) The device:
| Product Name | Calibrator Part
/ BAN Number |
|------------------------|-----------------------------------|
| Lipoprotein Calibrator | 00848903 |
- Contract Manufacturing Site: e) Medical Analysis Systems, Inc. (MAS) 5300 Adolfo Road Camarillo, CA 93012
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3. Predicate Device:
| Product Name | Calibrator Part # |
|---|---|
| Lipoprotein Calibrator | 00848903 |
Contract Manufacturing Site: Medical Analysis Systems, Inc. (MAS) 5300 Adolfo Road Camarillo, CA 93012
510(k) Number: K031682
4. Description of the device:
The Lipoprotein Calibrator is a human serum based solution containing various non human and human constituents,
5. Statement of Intended Use
Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1, Apolipoprotein B assays and Direct HDL on the ADVIA IMS Chemistry systems.
6. Product Performance
The stability of the Lipoprotein calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use.
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7. Substantial Equivalence:
| Feature | Predicate Lipoprotein
Calibrator (K031682) | Proposed Lipoprotein
Calibrator (addition of
assigned value for Direct
HDL Cholesterol Method) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bayer Lipoprotein Calibrator
is intended for in vitro
diagnostic use to calibrate
apolipoprotein A1 and
apolipoprotein B assays on
the ADVIA IMS chemistry
systems | Bayer Lipoprotein Calibrator
is intended for in vitro
diagnostic use to calibrate
apolipoprotein A1,
apolipoprotein B and Direct
HDL cholesterol assays on
the ADVIA IMS chemistry
systems |
| Format | Lyophilized mixture of human
and bovine serum base to
which appropriate human and
bovine constituents have
been added to achieve
specific concentrations. | Same |
| Constituent Analytes | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol* | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol |
| Stability | Stable at 2-8°C until the
expiration date printed on
the label. Stable 3 days when
reconstituted according to
directions when
refrigerated at 2-8°C | Same |
| Levels | Six levels for Apolipoprotein
A1 and Apolipoprotein B | Six levels for Apolipoprotein
A1 and Apolipoprotein B and
a single level for the Direct
HDL Cholesterol method |
- Please note: The predicate device already contained HDL Cholesterol as an analyte so the manufacturing process did not change, however Bayer did not assign any values for Direct HDL Cholesterol method at the time of the predicate device submission.
ea 27
Andres Holle Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/14/2005
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is displayed in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
AUG 1 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC 511 Benedict Avenue Tarrytown, NY 10591
Re: K051619 Trade/Device Name: Lipoprotein for Multiple Analytes Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 9, 2005 Received: June 17, 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
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Page 3 –
:
cc: HFZ-401 DMC
D.O.
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Indications for Use
510(k) Number (if known): K051619
Device Name: Lipoprotein Calibrator
Indications For Use:
The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to The Bayer Lipoprotein Oalibrator in Internation in the Direct HDL assays on the ADVIA® IMS Chemistry 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)
AC
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K051619
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