(26 days)
Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems.
The Lipoprotein Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bayer Healthcare Lipoprotein Calibrator:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's stability as a key performance characteristic and compares it to a predicate device, rather than explicit numerical acceptance criteria.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Bayer Lipoprotein Calibrator) | Predicate Device Performance (Bayer SETpoint™ Calibrator) |
|---|---|---|---|
| Intended Use | Calibrate Apolipoprotein A1 and Apolipoprotein B assays on ADVIA IMS Chemistry systems. | Intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on ADVIA IMS Chemistry systems. | For use as a calibrator of clinical chemistry assays for automated analytical procedures. |
| Format | Lyophilized human/bovine serum base with appropriate human constituents for specific concentrations. | Lyophilized mixture of human and bovine serum base to which appropriate human constituents have been added to achieve specific concentrations. | Lyophilized bovine serum base to which appropriate nonhuman constituents have been added to achieve specific concentrations. |
| Stability (Unreconstituted) | Stable at 2-8°C until expiration date. | Stable at 2-8°C until the expiration date printed on label. | Stable at 2-8°C until last day of the month (expiration date) printed on the label. |
| Stability (Reconstituted) | Stable for a defined period when refrigerated at 2-8°C according to directions. | Stable 3 days when reconstituted according to directions when refrigerated at 2-8°C. | Stable 48 hours when reconstituted according to directions when refrigerated at 2-8°C and protected from light (with exceptions for bilirubin). |
| Levels | Single Level Calibration. | Single Level | Single Level |
Study Proving Acceptance Criteria:
The document states: "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."
This indicates an internal validation study was performed by Bayer, focusing on the stability of the calibrator over time and under specified conditions, using multiple manufacturing lots.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "three separate lots of calibrator material." This refers to the manufacturing lots of the calibrator itself, not patient samples or a test set in the traditional sense for diagnostic accuracy.
- Data Provenance: The data was generated by Bayer Healthcare. The country of origin is not explicitly stated for the testing, but Bayer Healthcare is a global company. The study is prospective in nature, as it involves testing the stability of newly manufactured calibrator lots.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this device. This device is a calibrator, meaning its "truth" is its measured concentration of specified analytes (Apolipoprotein A1 and B) which it is designed to maintain. The "ground truth" would be established by analytical methods to determine the target concentrations of these analytes within the calibrator material, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" in the sense of patient data requiring adjudication. The performance evaluation focuses on the analytical stability of the calibrator itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a calibrator, not an imaging or diagnostic device that requires human interpretation or comparison against other diagnostic methods in a clinical setting.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical calibrator for laboratory assays, not a software algorithm. Its "performance" refers to its ability to maintain stable and accurate assigned values for calibrating other instruments.
7. Type of Ground Truth Used:
The ground truth for this device (a calibrator) would be the analytically determined concentration values of Apolipoprotein A1 and Apolipoprotein B within the calibrator material. These values are established through rigorous reference methods and material characterization during the manufacturing and quality control processes.
8. Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or an "algorithm" requiring a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Assigned 510(k) number: K031682
Bayer Healthcare Lipoprotein Calibrator Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Kenneth T. Edds Ph.D. Contact person: Address: Baver Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591 Phone: (914) 524-2446 FAX: (914) 524-2500 ken.edds.b.@bayer.com e-mail:
Date Summary Prepared:
2. Device Information
Proprietary Name: Common Name:
Lipoprotein Calibrator Calibrator for multiple analytes
Classification Name: Class: CFR: Product Code:
Calibrator §862.1150. Class II 862.1150 75 JIX
May 21, 2003
Contract Manufacturing Site: Medical Analysis Systems, Inc. (MAS) 5300 Adolfo Rd. Camarillo, CA 93012
3. Predicate Device Information
Name: SetPoint Chemistry Calibrator
Contract Manufacturing Site: Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645
510(k) Number:
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4. Device Description
The Lipoprotein Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
5. Statement of 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.
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.
| Characteristic | Bayer LipoproteinCalibrator | Bayer SETpoint™Calibrator for AutomatedSystems |
|---|---|---|
| Intended Use | Bayer LipoproteinCalibrator is intended for invitro diagnostic use tocalibrate apolipoprotein A1and apolipoprotein Bassays on the ADVIA IMSchemistry systems. | For use as a calibrator ofclinical chemistry assays forautomated analyticalprocedures. |
| Format | Lyophilized mixture ofhuman and bovine serumbase to which appropriatehuman constituents havebeen added to achievespecific concentrations. | Lyophilized bovine serumbase to which appropriatenonhuman constituentshave been added toachieve specificconcentrations. |
| Stability | Stable at 2-8°C until theexpiration date printedon label. Stable 3 days whenreconstituted accordingto directions whenrefrigerated at 2-8°C. | Stable at 2-8°C until lastday of the month(expiration date) printedon the label. Stable 48 hours whenreconstituted accordingto directions whenrefrigerated at 2-8°Cand protected from lightwith the exception oftotal and direct bilirubin,which are stable foreight hours. |
| Levels | Single Level | Single Level |
7. Comparison to Predicate Device
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Comparison of predicate device and proposed Bayer Lipoprotein Calibrator
| Bayer Lipoprotein Calibrator(New Device) | Bayer SETpoint™ Chemistry Calibrator(Predicate Device) |
|---|---|
| APOLIPOPROTEIN A1 | ALBUMIN |
| APOLIPOPROTEIN B | BILIRUBIN, DIRECT |
| BILIRUBIN, TOTAL | |
| CALCIUM | |
| CHOLESTEROL | |
| CREATININE | |
| GLUCOSE | |
| IRON | |
| MAGNESIUM | |
| PHOSPHORUS, INORGANIC | |
| TOTAL PROTEIN | |
| TRIGLYCERIDES | |
| UREA NITROGEN | |
| URIC ACID | |
| SODIUM | |
| POTASSIUM | |
| CHLORIDE |
Constituent Analytes
and and the management of the same of the same of the same of the same of the same of
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2003
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K031682
Trade/Device Name: Lipoprotein Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 23, 2003 Received: May 30, 2003
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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page __ of _1
510(k) Number: K () 31682
Device Name: Lipoprotein Calibrator
Indications for 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)
Allent Smith
Division Sign-Off for Jean C
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031682
§ 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.