(14 days)
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No
The document describes a chemical calibrator solution and its intended use for calibrating laboratory chemistry systems. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is a calibrator for in vitro diagnostic use, not a device intended for treating or diagnosing a medical condition in a patient.
No.
This device is a calibrator for in vitro diagnostic systems, not a diagnostic device itself. Its purpose is to ensure the accuracy of other diagnostic equipment.
No
The device description explicitly states it is a "bovine 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 SETpoint Calibrator is intended for in vitro diagnostic use..."
This statement directly identifies the device as an IVD.
N/A
Intended Use / Indications for Use
Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The SETpoint Chemistry Calibrator is a bovine serum based solution containing various nonhuman constituents at defined concentrations.
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)
The stability of the SETpoint 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.
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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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§ 862.1150 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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JAN 3 1 2003
Image /page/0/Picture/1 description: The image shows the Bayer company logo. The word "Bayer" is written in a bold, sans-serif font on the left side of the image. To the right of the word is a circle with the word "Bayer" written vertically inside of it. The letters are stacked on top of each other, with the "A" in the middle.
Assigned 510(k) number: 13030109
Bayer Healthcare SETpoint Chemistry Calibrator Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Contact person:
Kenneth T. Edds Ph.D.
Address: Bayer Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591
Phone: FAX: e-mail: (914) 524-2446 (914) 524-2500 ken.edds.b.@bayer.com
Date Summary Prepared:
January 15, 2003
2. Device Information
Proprietary Name: Common Name:
Classification Name:
Product Code:
Class:
CFR:
SETpoint Chemistry Calibrator Calibrator for multiple analytes
Calibrator §862.1150. Class II 862.1150 75 JIX
3. Predicate Device Information
Name:
Calibrator for automated systems
Roche Diagnostics Corp.
Indianapolis, IN 46250
510(k) Number:
Manufacturer:
9115 Hague Rd.
Business Group Diagnostics
Baver Corporation 511 Benedict Avenue
Tarrytown, NY 10591-5097 Phone: 914 631-8000 Fax: 914 524-2132 http://www.bayerdiag.com
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4. Device Description
The SETpoint Chemistry Calibrator is a bovine serum based solution containing various nonhuman constituents at defined concentrations.
5. Statement of Intended Use
Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.
6. Product Performance
The stability of the SETpoint 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 SETpoint Calibrator | Roche Calibrator for
Automated Systems |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bayer SETpoint Calibrator is
intended for in vitro diagnostic
use to calibrate the following
systems: Technicon RA and
opeRA Chemistry Systems,
Technicon RA-100, Technicon
DAX, ADVIA 1650/ADVIA
2400 Chemistry systems, and
ADVIA IMS Chemistry systems. | For use as a calibrator of clinical
chemistry assays for automated
analytical procedures. |
| Format | Lyophilized bovine serum base to
which appropriate nonhuman
constituents have been added to
achieve specific concentrations. | Lyophilized pooled human serum
with constituents added as
required to obtain desired
component levels. |
| Stability | Stable at 2-8°C until last day
of the month (expiration
date) printed on 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. | Stable at 2-8°C until
expiration date. Stable 2 days when
reconstituted, stoppered,
protected from light and
stored at 2-8°C, with
exceptions noted in labeling. |
| Levels | Single Level | Single Level |
7. Product Characteristics
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| Constituent Analytes | |
|---|---|
| Bayer SETpoint | |
| (New Device) | Roche Calibrator for Automated Systems (C.f.a.s) |
| (Predicate Device) | |
| ALBUMIN | ALBUMIN |
| BILIRUBIN, DIRECT | BILIRUBIN, DIRECT |
| BILIRUBIN, TOTAL | BILIRUBIN, TOTAL |
| CALCIUM | CALCIUM |
| CHOLESTEROL | CHOLESTEROL |
| CREATININE | CREATININE |
| GLUCOSE | GLUCOSE |
| IRON | IRON |
| MAGNESIUM | MAGNESIUM |
| PHOSPHORUS, INORGANIC | PHOSPHORUS, INORGANIC |
| TOTAL PROTEIN | TOTAL PROTEIN |
| TRIGLYCERIDES | TRIGLYCERIDES |
| UREA NITROGEN | UREA NITROGEN |
| URIC ACID | URIC ACID |
| SODIUM | SODIUM |
| POTASSIUM | POTASSIUM |
| CHLORIDE | CHLORIDE |
| LACTATE | |
| PHOSPHOLIPIDS | |
| SALICYLATE | |
| UNSATURATED IRON-BINDING CAPACITY | |
| ACID PHOSPHATASE | |
| ALKALINE PHOSPHATASE | |
| ALANINE AMINOTRANSFERASE | |
| ALPHA-AMYLASE | |
| PANCREATIC ALPHA-AMYLASE | |
| ASPARTATE AMINOTRANSFERASE | |
| CHOLINESTERASE | |
| CREATINE KINASE | |
| GAMMA-GLUTAMYLTRANSERASE | |
| GLUTAMATE DEHYDROGENASE | |
| ALPHA-HYDROXYBUTYRATE DEHYDROGENASE | |
| LACTATE DEHYDROGENASE | |
| LIPASE | |
| BICARBONATE | |
| UIBC | |
| LDI |
:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 3 1 2003
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Healthcare, LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K030169
Trade/Device Name: SETpoint Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: January 16, 2003 Received: January 17, 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 1 of 1
K030169 510(k) Number (if known):
Device Name: SETpoint Chemistry Calibrator
Indications for Use:
. . .
・
1000
Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.
Jean Cooper
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Per 21 CFR 801.109)