(45 days)
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.
The Lipoprotein Calibrator is a human serum based solution containing various non human and human constituents.
The provided document describes a 510(k) premarket notification for a Lipoprotein Calibrator. This document primarily focuses on establishing substantial equivalence to a predicate device and does not detail a study with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.
However, based on the information provided, here's an interpretation of the "acceptance criteria" and "study" as they pertain to this calibrator, framed to match the requested format:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Calibrates Apolipoprotein A1, Apolipoprotein B, and Direct HDL assays on ADVIA IMS Chemistry systems. | The device's intended use includes calibrating Direct HDL cholesterol assays, which was the focus of this submission. It is deemed to perform similarly to other products for similar use. |
| Format: Lyophilized mixture of human and bovine serum base with appropriate constituents. | "Same" as predicate device. |
| Constituent Analytes: Apolipoprotein A1, Apolipoprotein B, HDL Cholesterol. | "Same" as predicate device; the difference is assigning values for Direct HDL. |
| Stability: Stable at 2-8°C until expiration; stable 3 days when reconstituted at 2-8°C. | "Same" as predicate device. Stability validated according to Bayer procedures. |
| Levels: Six levels for Apolipoprotein A1 and Apolipoprotein B; a single level for Direct HDL Cholesterol method. | Achieved: "a single level for the Direct HDL Cholesterol method" was added to the existing six levels for other analytes. |
| Equivalent Performance: Performance similar to other products in commercial distribution intended for similar use. | "The performance of the calibrator is similar to other products in commercial distribution intended for similar use." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of typical device validation. The "study" focused on stability validation and demonstrating substantial equivalence. The document mentions "three separate lots of calibrator material" were used for stability validation.
- Data Provenance: Not specified, but given the context of Bayer HealthCare LLC in Tarrytown, NY, and Medical Analysis Systems, Inc. (MAS) in Camarillo, CA, it is likely retrospective testing performed internally by the manufacturer, or under their direction, within the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a calibrator, "ground truth" would typically refer to the accurately assigned values of the analytes within the calibrator material, which are established through rigorous metrological traceability, reference methods, and internal quality control, rather than expert consensus on a test set.
4. Adjudication method for the test set
- Not applicable / Not specified. The document does not describe an "adjudication method" as would be used for subjective assessments or interpretations. The evaluation of a calibrator involves objective analytical measurements.
5. 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
- No. This document describes a medical device calibrator, not an AI-driven or interpretation-based diagnostic device. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a calibrator, a reagent used to standardize assays, not an algorithm or standalone diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a calibrator's values is established by analytical methods, reference materials, and metrological traceability, ensuring that the assigned values for Apolipoprotein A1, Apolipoprotein B, and Direct HDL cholesterol are accurate and consistent. This is an intrinsic property of the calibrator material itself, based on its chemical composition and precise measurement, rather than expert consensus on a clinical outcome.
8. The sample size for the training set
- Not applicable. This submission focuses on a calibrator, not a machine learning model, so there is no "training set" in the AI sense. The "training" in manufacturing involves process controls and validation using material lots. The document states validation based on "three separate lots of calibrator material."
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for an AI model, this question is not relevant. The "truth" for the calibrator lots used in performance validation (stability) would be established by the manufacturer's internal analytical methods and quality control processes to assign specific, traceable values to the analytes within the calibrator.
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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 LipoproteinCalibrator (K031682) | Proposed LipoproteinCalibrator (addition ofassigned value for DirectHDL Cholesterol Method) |
|---|---|---|
| Intended Use | Bayer Lipoprotein Calibratoris intended for in vitrodiagnostic use to calibrateapolipoprotein A1 andapolipoprotein B assays onthe ADVIA IMS chemistrysystems | Bayer Lipoprotein Calibratoris intended for in vitrodiagnostic use to calibrateapolipoprotein A1,apolipoprotein B and DirectHDL cholesterol assays onthe ADVIA IMS chemistrysystems |
| Format | Lyophilized mixture of humanand bovine serum base towhich appropriate human andbovine constituents havebeen added to achievespecific concentrations. | Same |
| Constituent Analytes | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol* | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol |
| Stability | Stable at 2-8°C until theexpiration date printed onthe label. Stable 3 days whenreconstituted according todirections whenrefrigerated at 2-8°C | Same |
| Levels | Six levels for ApolipoproteinA1 and Apolipoprotein B | Six levels for ApolipoproteinA1 and Apolipoprotein B anda single level for the DirectHDL 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
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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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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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.