(48 days)
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No
The summary describes a standard immunoassay and calibrator for measuring C-peptide, with no mention of AI or ML in the intended use, device description, or performance studies. The performance metrics are standard for laboratory assays.
No.
The device is a calibrator and immunoassay used for diagnostic purposes (quantitative determination of C-peptide in human serum to aid in diagnosis and treatment), not for directly treating a disease or condition.
Yes
The device aids in the diagnosis and treatment of patients with abnormal insulin secretion, which is a diagnostic purpose.
No
The device description clearly states it is a physical calibrator (citric acid buffered saline with casein and preservatives) used for calibrating an immunoassay, indicating it is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are used for calibrating immunoassays that determine C-peptide in human serum. This is a biological sample taken from the human body.
- Purpose: The purpose of the immunoassay (which the calibrators are used for) is to "aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus." This is a diagnostic purpose.
- Device Description: The device is a "citric acid buffered saline with casein and preservatives," which is a reagent used in laboratory testing.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ACS:180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS:180 and ADVIA Centaur C-peptide Immunoassays.
The ACS:180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
75 JIT
Device Description
The ACS:180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered saline with casein and preservatives (micro-protect).
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)
Substantial equivalence to the AIA-PACK C-Peptide Calibrator Set is based on comparison of the control accuracy and precision of the ADVIA Centaur and ACS:180 to the predicate device.
| System | Sample ID | Mean | Within Run%CV | Total%CV | % Recovery vs TOSOH |
|---|---|---|---|---|---|
| AIA TOSOH | Level 1 | 1.71 | 2.8 | 5.7 | |
| Level 2 | 5.23 | 2.0 | 5.8 | ||
| ACS:180 | Level 1 | 1.63 | 4.3 | 9.8 | 95.3 |
| Level 2 | 5.22 | 3.2 | 6.1 | 99.8 | |
| Level 3 | 11.72 | 3.6 | 7.6 | NA | |
| ADVIA Centaur | Level 1 | 1.43 | 3.7 | 6.1 | 83.6 |
| Level 2 | 4.88 | 4.0 | 5.1 | 93.3 | |
| Level 3 | 10.60 | 4.1 | 6.2 | NA |
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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Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters. The sequence starts with the letters 'KO', followed by the numbers '21532'. The characters are written in a dark color, possibly with a pen or pencil, against a light background. The handwriting appears somewhat stylized.
Bayer Diagnostics ASC:180 and ADVIA Centaur C-peptide Calibrator Section 2: 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 Diagnostics Corporation |
| 511 Benedict Ave. | |
| Tarrytown, NY 10591 | |
| Phone: | (914) 524-2446 |
| FAX: | (914) 524-2500 |
| e-mail: | ken.edds.b@bayer.com |
| Date Summary Prepared: | April 29, 2002 |
| 2. Device Information | |
| Proprietary Name: | ADVIA Centaur and ACS:180 C-peptide |
| Calibrator | |
| Common Name: | Calibrator for immunoassay analyte |
| Classification Name: | Calibrator §862.1150. |
| Class: | Class II |
| CFR: | 862.1150 |
| Product Code: | 75 JIT |
| 3. Predicate Device Information | |
| Name: | AIA-PACK C-Peptide Calibrator Set |
| Manufacturer: | TOSOH Corporation |
| TOSOH Kyobashi Building | |
| 3-2-4 Kyobashi, Chuo-ku, Tokyo 104-0031 | |
| Japan | Phone: +81-(3)-3275-1221 |
| Fax: +81-(3)-3275-1214 |
510(k) Number:
1
4. Device Description
The ACS:180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered saline with casein and preservatives (micro-protect).
5. Statement of Intended Use
For use in calibrating the ADVIA Centaur and ACS:180 C-peptide immunoassays on the automated analyzers marketed by Bayer Corporation.
6. Summary of Technological Characteristics
The ADVIA Centaur and ACS:180 C-peptide Calibrators are similar to the TOSOH Corporation AIA-PACK C-Peptide Calibrator Set (K971998) in the indications for use, and reference method for standardization, WHO 84/510. In the ACS:180 and ADVIA Centaur Cpeptide calibrator a buffer base is used to replace the protein matrix used in the TOSOH Corporation AIA-PACK C-Peptide Calibrator Set.
7. Accuracy and Precision
The commercial control dose data represented in this document was generated using the calibrators for each respective C-peptide immunoassay.
Substantial equivalence to the AIA-PACK C-Peptide Calibrator Set is based on comparison of the control accuracy and precision of the ADVIA Centaur and ACS:180 to the predicate device.
| System | Sample ID | Mean | Within Run
%CV | Total
%CV | % Recovery
vs TOSOH |
|---------------|-----------|-------|-------------------|--------------|------------------------|
| AIA TOSOH | Level 1 | 1.71 | 2.8 | 5.7 | |
| | Level 2 | 5.23 | 2.0 | 5.8 | |
| ACS:180 | Level 1 | 1.63 | 4.3 | 9.8 | 95.3 |
| | Level 2 | 5.22 | 3.2 | 6.1 | 99.8 |
| | Level 3 | 11.72 | 3.6 | 7.6 | NA |
| ADVIA Centaur | Level 1 | 1.43 | 3.7 | 6.1 | 83.6 |
| | Level 2 | 4.88 | 4.0 | 5.1 | 93.3 |
| | Level 3 | 10.60 | 4.1 | 6.2 | NA |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 7 2002
Kenneth T. Edds, Ph.D. Manager. Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K021532
Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur C-peptide Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: May 3, 2002 Received: May 10, 2002
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. 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known):
Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur C-peptide Calibrator
Indications for Use:
The ACS:180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS:180 and ADVIA Centaur C-peptide Immunoassays.
The ACS:180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number