(26 days)
Not Found
No
The summary describes a calibrator solution for a chemistry system, with no mention of AI/ML or related concepts.
No
This device is an in vitro diagnostic calibrator, used to calibrate assays, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "intended for in vitro diagnostic use".
No
The device description explicitly states it is a "human serum based solution containing various nonhuman constituents," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems."
This statement clearly indicates that the device is intended for use outside of the body to diagnose or aid in the diagnosis of a condition.
N/A
Intended Use / 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.
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 nonhuman constituents at defined concentrations.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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.)
Not Found
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.
0
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:
1
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 Lipoprotein
Calibrator | Bayer SETpoint™
Calibrator for Automated
Systems |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | For use as a calibrator of
clinical chemistry assays for
automated analytical
procedures. |
| Format | 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 | Stable at 2-8°C until the
expiration date printed
on label. Stable 3 days when
reconstituted according
to directions when
refrigerated at 2-8°C. | Stable at 2-8°C until last
day of the month
(expiration date) printed
on the label. Stable 48 hours when
reconstituted according
to directions when
refrigerated at 2-8°C
and protected from light
with the exception of
total and direct bilirubin,
which are stable for
eight hours. |
| Levels | Single Level | Single Level |
7. Comparison to Predicate Device
2
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
3
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).
4
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
5
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