(24 days)
Not Found
No
The description focuses on the chemical reagents and the automated chemistry system for measuring HbA1c and Hb. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is for in vitro diagnostic use only, specifically for determining the percentage of glycated hemoglobin (%A1c) as a diagnostic and monitoring tool, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and describes the kit's use to "determine the percent glycated hemoglobin (%A1c) in human whole blood...effective in monitoring long-term glycemic control in individuals with diabetes mellitus." This directly aligns with the definition of a diagnostic device.
No
The device description clearly outlines physical components including reagent kits, calibrator kits, and mentions the use of a VITROS 5,1 FS Chemistry System, which is a hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use only." This is a clear indicator that the device is intended for use outside of the body to diagnose or monitor a condition.
- "VITROS Chemistry Products d%A1c Reagent Kit is used to determine the percent glycated hemoglobin (%A1c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c)." This describes the specific diagnostic test being performed on a biological sample (human whole blood).
- "Measurements of percentage A1c are effective in monitoring long-term glycemic control in individuals with diabetes mellitus." This further clarifies the diagnostic purpose of the test in managing a specific medical condition.
The descriptions of the calibrator kits also state "For in vitro diagnostic use only," indicating they are components used in the IVD process.
The "Device Description" details the reagents and calibrators used to perform the assay on a chemistry system, which is consistent with an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products d%A1c Reagent Kit is used to determine the percent glycated hemoglobin (%A1c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage Alc are effective in monitoring long-term glycemic control in individuals with diabetes mellitus.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%A1c).
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19 and 28 to calibrate VITROS 5,1 FS Chemistry Systems.
Product codes
LCP, JIT
Device Description
- VITROS Chemistry Products d%A1c Reagent Kit, VITROS Chemistry Products Calibrator Kit 18, and VITROS Chemistry Products FS Calibrator 1 are combined with the VITROS 5,1 FS Chemistry System to perform the VITROS d%A1c assay.
a. VITROS d%A1c Reagent Kit contains two unique dual chambered reagent packs containing ready to use liquid reagents that are used to measure both hemoglobin A1c (HbA1c) and hemoglobin (Hb).
i. Hemoglobin A1c Reagent Pack (HbA1c)
- The R1 chamber (HbA1c Reagent 1) consists of:
a. HbA1c antibody (ovine serum)
b. Buffers
c. Stabilizers
d. Preservatives - The R2 chamber (HbA1c Reagent 2) consists of:
a. HbAlc Polyhapten
b. Buffers
c. Stabilizers
d. Preservatives
ii. Hemoglobin Reagent Pack (Hb)
- The R1 chamber (Hb Reagent 1) consists of:
a. Buffer
b. Stabilizers
c. Preservatives - The R2 chamber (Hb Reagent 2) contains Hemolyzing Reagent, which consists of:
a. Tetradecyltrimethylammonium bromide (TTAB)
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
Summary Information
510(k) Summary
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: K060650
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- Submitter Ortho-Clinical Diagnostics, Inc. name. 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-3143
Contact Person: Michael M. Byrne
- Submitter Ortho-Clinical Diagnostics, Inc. name. 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-3143
-
- Preparation Date Special 510(k) prepared: March 10, 2006 date
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- Device Trade or Proprietary Name: name VITROS Chemistry Products d%A1c Reagent Kit VITROS Chemistry Products Calibrator Kit 18 VITROS Chemistry Products FS Calibrator 1 Common Name : Glycohemoglobin assay Classification Name: Glycosylated hemoglobin assay (21 CFR 864.7470).
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- Predicate The VITROS Chemistry Products d%A1c Reagent Kit (modified), VITROS device Chemistry Products Calibrator Kit 18 and VITROS Chemistry Products FS Calibrator 1 are substantially equivalent to VITROS Chemistry Products %A1c Reagent Kit (current), VITROS Chemistry Products Calibrator Kit 18, and VITROS FS Calibrator 1 which were cleared by the FDA for in vitro diagnostic use.
VITROS %A1c Reagent Kit: (K041764, Cleared September 9, 2004) VITROS Calibrator Kit 18: (K041764, Cleared September 9, 2004) VITROS FS Calibrator 1: (K052645, Cleared December 14, 2005).
1
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- VITROS Chemistry Products d%A1c Reagent Kit, VITROS Chemistry 5. Device description Products Calibrator Kit 18, and VITROS Chemistry Products FS Calibrator 1 are combined with the VITROS 5,1 FS Chemistry System to perform the VITROS d%A1c assay.
- a. VITROS d%A1c Reagent Kit contains two unique dual chambered reagent packs containing ready to use liquid reagents that are used to measure both hemoglobin A1c (HbA1c) and hemoglobin (Hb).
i. Hemoglobin A1c Reagent Pack (HbA1c)
-
- The R1 chamber (HbA1c Reagent 1) consists of:
- a. HbA1c antibody (ovine serum)
- b. Buffers
- c. Stabilizers
- d. Preservatives
-
- The R2 chamber (HbA1c Reagent 2) consists of:
- a. HbAlc Polyhapten
- b. Buffers
- c. Stabilizers
- d. Preservatives
ii. Hemoglobin Reagent Pack (Hb)
-
- The R1 chamber (Hb Reagent 1) consists of:
- a. Buffer
- b. Stabilizers
- c. Preservatives
-
- The R2 chamber (Hb Reagent 2) contains Hemolyzing Reagent, which consists of:
- a. Tetradecyltrimethylammonium bromide (TTAB) Equivalence was demonstrated using manufactured reagents along with patient and quality control samples with measured %A1c values spanning the reportable range.
The information presented in this premarket notification provides a reasonable assurance that the VITROS Chemistry Products d%A1c assay for use with human whole blood is safe and effective for the stated intended use.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The eagle is black and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 6 2006
Mr. Michael M. Byrne Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K060650
Trade/Device Name: VITROS Chemistry Products d%A1c Reagent Kit VITROS Chemistry Products Calibrator Kit 18 VITROS Chemistry Products FS Calibrator 1 Regulation Number: 21 CFR8864.7470 Regulation Name: Glycosylated hemoglobin assay
Regulatory Class: Class II
Product Code: LCP, JIT
Dated: March 10. 2006
Received: March 13, 2006
Dear Mr. Byrne:
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 ean 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 (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 vours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name:
Image /page/7/Picture/4 description: The image shows a handwritten text "Kd60650" in black ink. The text appears to be a code or identifier, with a mix of uppercase letters and numbers. A horizontal line is present beneath the text, possibly indicating an underline or a separation mark.
VITROS Chemistry Products d%A1c Reagent Kit VITROS Chemistry Products Calibrator Kit 18 VITROS Chemistry Products FS Calibrator 1
For in vitro diagnostic use only. Indications for Use: VITROS Chemistry Products d%A1c Reagent Kit is used to determine the percent glycated hemoglobin (%A1c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage Alc are effective in monitoring long-term glycemic control in individuals with diabetes mellitus.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%A1c).
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19 and 28 to calibrate VITROS 5,1 FS Chemistry Systems.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060650