(55 days)
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No
The document describes a calibrator material for a chemistry analyzer and does not mention any AI or ML components or functions.
No
The device is a calibrator for in vitro diagnostic use, intended to calibrate a chemistry system, not to treat or diagnose a disease.
No
This device is a calibrator for a diagnostic system, not a diagnostic device itself. Its purpose is to calibrate the ADVIA 1650 Chemistry system, which then performs diagnostic tests.
No
The device is a physical calibrator material (lyophilized human serum with added constituents) requiring reconstitution, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states: "For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods."
This statement clearly indicates that the device is intended to be used outside of the body (in vitro) for diagnostic purposes (calibration of a chemistry system used for diagnostic testing).
N/A
Intended Use / Indications for Use
The Special Chemistry Calibrators are calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analvzer.
For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.
All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC
The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC
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)
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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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DEC 1 6 2003
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number is: K033380
Submitter's Name and Address
Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235
Contact Person: Andres Holle Telephone: 914-524-3494 Fax: 914-524-2500 e-mail: andres.holle.b@bayer.com
Contract Manufacturer
Randox Laboratories 55 Diamond Road Crumlin, County Antrim, UK Establishment Registration: 8020890
| Device Name: | Special Chemistry Calibrator |
|---|---|
| Proprietary/Trade Name | Bayer ADVIA 1650 Special |
| Chemistry Calibrator | |
| Common Name: | Calibrator Material |
| Classification Name: | Calibrator |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIX |
| Predicate Device: | Bayer Special Chemistry Calibrator |
| Premarket Notification Number: K030804 |
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Device Description:
The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.
All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC
The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC
Intended Use:
The Special Chemistry Calibrators are calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analvzer.
Substantial Equivalence:
The Special Chemistry Calibrators are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Direct TIBC.
As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is rendered in black and white.
DEC 1 6 2003
Food and Drug Administration 2098 Gaither Road
Public Health Service
Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
Re: K033380
Trade/Device Name: Special Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 16, 2003 Received: October 23, 2003
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 (OS) regulation (21 CFR Part 820).
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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). Other general information on your responsibilities under the Act may be obtained 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 Butman
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
| 510(k) Number (if known): | K033380 |
|---|---|
| --------------------------- | --------- |
Device Name: Special Chemistry Calibrator
Indications for Use:
For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.
(PLEASE DO NOT WRITE BELOW THIS LINE---- CONTINUE ON ANOTHER PAGE, IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| (ODE) |
| Prescription Use Use | X | OR | Over-The-Counter |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| 1-2-96) | (Optional Format) |
Carol C Benem for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033380