(23 days)
No
The summary describes a calibrator for a clinical chemistry analyzer, which is a chemical reagent used for calibration, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is a calibrator for laboratory tests, not a device used for treating disease.
No
This device is described as a calibrator used to ensure optimal calibration of quantitative Roche methods on clinical chemistry analyzers. Calibrators are used to make sure a diagnostic device is working properly, but they are not diagnostic devices themselves.
No
The device description clearly states it is a lyophilized calibrator based on hemolyzed sheep blood and human blood, which are physical substances, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of quantitative Roche methods on Roche clinical chemistry analyzers". Clinical chemistry analyzers are used to perform tests on biological samples (like blood) in vitro (outside the body) to diagnose or monitor medical conditions. Calibration is a crucial step in ensuring the accuracy of these in vitro tests.
- Device Description: The description mentions it's a "lyophilized calibrator based on hemolyzed sheep blood and human blood". This indicates it's a reagent or material used in the process of performing in vitro diagnostic tests.
- Predicate Device: The mention of a predicate device (K934070; calibrator included in the Tina-Quant HbA1c reagent kit) further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs that a new device is compared to for regulatory purposes.
Therefore, the purpose and nature of the device align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Product codes
KRZ
Device Description
C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a)
Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.(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 § 864.9.
0
510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3723 | |
| Contact person: Theresa M. Ambrose | |
| Date prepared: August 2, 2005 | |
| Device name | Proprietary name: C.f.a.s. (Calibrator for Automated Systems) HbA1c |
| Common name: calibrator for Hemoglobin measurements | |
| Classification name: Calibrator for hemoglobin or hematocrit measurement | |
| Device description | C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels. |
| Intended use | C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. |
| Predicate device | We claim substantial equivalence to the calibrator included in the Tina-Quant HbA1c reagent kit, originally cleared under K934070. |
| C.f.a.s. HbA1c is identical to this calibrator; however, it is now being provided at a single-level and sold as a separate product. |
Continued on next page
1
510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c, Continued
The table below indicates the similarities between the modified C.f.a.s. Substantial (Calibrator for Automated Systems) HbA1c and its predicate device equivalency -(calibrator in Tina-Quant HbA1c test system, K934070). similiarities
| Characteristic | Predicate calibrator | C.f.a.s. HbA1c |
|---|---|---|
| Intended Use | Calibrator included in kit | |
| for calibration of the | ||
| quantitative Tina-Quant | ||
| HbA1c method. | C.f.a.s. (Calibrator for | |
| automated systems) HbA1c is | ||
| for use in the calibration of | ||
| quantitative Roche methods | ||
| on Roche clinical chemistry | ||
| analyzers as specified in the | ||
| enclosed value sheet. | ||
| Format | Lyophilized | Same |
| Matrix and composition | Hemolysate derived from | |
| human and sheep blood; | ||
| 0.9% TTAB | ||
| (tetradecyltrimethylamm | ||
| onium bromide); | ||
| stabilizers | Same |
Continued on next page
2
510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c, Continued
The table below indicates the differences between the modified C.f.a.s. Substantial (Calibrator for Automated Systems) HbA1c and its predicate device equivalency -(calibrator in Tina-Quant HbA1c test system, K934070). differences
| Characteristic | Predicate calibrator | C.f.a.s. HbA1c |
|---|---|---|
| Handling | Reconstitute with 1.0 mL distilled or deionized water. | Reconstitute with 2.0 mL distilled or deionized water. |
| Levels | Four levels | Single level |
| Stability | Unopened: stable up to the expiration date | Unopened: same |
| Reconstituted: | ||
| 2 days @ 2-8 °C | ||
| 8 hours @ 20-25 °C | ||
| 3 months @ -20 °C | Reconstituted: | |
| 2 days @ 2-8 °C | ||
| 8 hours @ 15-25 °C | ||
| 3 months @ (-15) to (-25) °C |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 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 symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
AUG 26 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose. Ph.D., RAC Regulatory Principal Roche Diagnostics Centralized Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K052101
Trade/Device Name: C.f.a.s. (Calibrator for Automated Systems) HbA1c Regulation Number: 21 CFR 864.8165 Regulation Name: Calibrator for hemoglobin or hematocrit measurement Regulatory Class: Class II Product Code: KRZ Dated: August 2, 2005 Received: August 3, 2005
Dear Ms. Ambrose:
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
KOS201
Device Name: C.f.a.s. (Calibrator for Automated Systems) HbA1c
Indications For Use:
C.f.a.s. (Calibrator for automated systems) HbA Ic is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
210(K)
Confidential