(58 days)
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No
The document describes a quality control material for chemistry systems and does not mention any AI or ML components.
No
The device is described as "For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods" and is a "quality control material prepared from human serum". This indicates it is for diagnostic purposes, not for treating a disease or condition.
No
Explanation: The device is a "quality control material" used for in vitro diagnostic control, not a diagnostic device itself. It helps ensure the accuracy of diagnostic equipment.
No
The device description clearly states it is a "quality control material prepared from human serum with nonserum constituents added," indicating it is a physical substance, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The statement "For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods" explicitly states its intended use is for in vitro diagnostics.
- Device Description: The description mentions it's a "quality control material prepared from human serum," which is a common component of IVD controls used to assess the performance of diagnostic tests.
The purpose of this device is to control the accuracy and reliability of chemistry tests performed on the ADVIA Chemistry systems, which are themselves IVD devices. This control material is used in vitro (outside the body) to verify the performance of the diagnostic methods.
N/A
Intended Use / Indications for Use
The Special Chemistry Controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA Chemistry analyzers.
For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.
Product codes
JJY
Device Description
The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added.
All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase Direct TIBC The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC As with the predicate device, the control materials are lyophilized and require reconstitution with 5.0 mL distilled water. These controls are only for use on the Bayer Chemistry Analyzers.
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 9 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: K033379
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
Special Chemistry Control Device Name: Bayer ADVIA Chemistry Special Proprietary/Trade Name Chemistry Control Quality Control Material Common Name: Classification Name: Enzyme Controls (assayed and unassayed) Class I
Classification: 21 CFR 862.1660 Regulation Number: Chemistry (75) Panel: JJY Product Code: Predicate Device: Bayer Special Chemistry Control Premarket Notification Number: K030801
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Device Description:
The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added.
All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase 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 Controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA Chemistry analyzers.
Substantial Equivalence:
The Special Chemistry Controls are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Controls. The only difference in these controls is the addition of the assigned values in the labeling of a new analyte: Direct TIBC.
As with the predicate device, the control materials are lyophilized and require reconstitution with 5.0 mL distilled water. These controls are only for use on the Bayer Chemistry Analyzers.
2
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 image of three birds in flight, depicted with thick, black lines. The birds are stacked vertically, with the largest bird at the top and the smallest at the bottom, creating a sense of upward movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2003
Mr. Andres Holle Manager, Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591
K033379 Trade/Device Name: Special Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 16, 2003 Received: October 22, 2003
Dear Mr. Holle:
Re:
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. Iisting 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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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 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 0333 510(k) Number (if known):
Device Name: Special Chemistry Control
Indications for Use:
For in vitro diagnostic use in the control of ADVIA Chemistry systems 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
(Per 21 CFR 801.109)
1-2-96)
OR
Over-The-Counter
(Optional Format
Carol C Benson for Jean Cooper, DV
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033379