(71 days)
No
The summary describes a standard automated clinical chemistry analyzer and associated reagents for measuring glycated hemoglobin. There is no mention of AI, ML, or any computational methods beyond standard analytical calculations.
No
The device is described as being "for in vitro diagnostic use only" and "is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens." Its purpose is to measure %A1c for monitoring long-term glucose control, which is a diagnostic function, not a therapeutic one.
Yes
The device is explicitly stated as being "For in vitro diagnostic use only", and it performs quantitative measurements of analytes in human blood to monitor long-term glucose control in individuals with diabetes mellitus.
No
The device description clearly outlines a system comprised of instrumentation, reagent kits, and thin film products, indicating it is a hardware-based system that utilizes software for operation, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" multiple times for the reagent kit, calibrator kit, and performance verifiers.
- Nature of the Test: The device is used to measure %A1c in pretreated human whole blood. This is a laboratory test performed on a biological sample outside of the body, which is the definition of an in vitro diagnostic test.
- Purpose of the Test: The measurement of %A1c is used for "monitoring long-term glucose control in individuals with diabetes mellitus," which is a diagnostic and monitoring purpose.
- Device Description: The device is described as a "fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens." This further confirms its role in in vitro testing.
The entire description points to a system designed for performing diagnostic tests on human samples in a laboratory setting.
N/A
Intended Use / Indications for Use
- For in vitro diagnostic use only. VITROS Chemistry Products %A1c Reagent Kit is used to calculate percent glycated hemoglobin (%A1c) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage Alc are effective in monitoring long-term glucose 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 %A1c Performance Verifiers are assayed controls used to monitor performance of %A1c Reagent Kit on VITROS 5,1 FS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIT, JJX
Device Description
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
-
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products %A1c Reagent Kit, VITROS Chemistry Products Hemolyzing Reagent, VITROS Chemistry Products Calibrator Kit 18, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products %A1c Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS %A1c assay.
-
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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)
Studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS %A1c assay. The relationship between the VITROS %A1c assay and the predicate device in NGSP units, determined by least squares linear regression, is: VITROS %A1c assay = 1.0374 X = 0.3426 %A1c with a correlation coefficient of 0.9872, where X is the Tosoh A1c 2.2 Plus Glycohemoglobin Assay on the TOSOH Automated Glycohemoglobin Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 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
1.0 510(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: KO417V4
1.1 Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3482 Fax: (585) 453-3368
Contact Person: Carey A. Mayo, M.S., RAC
1.2 Date of Preparation: June 29, 2004
1.3 Device Proprietary Name(s)
- VITROS Chemistry Products %A1c Reagent Kit Trade Name(s) VITROS Chemistry Products Hemolyzing Reagent VITROS Chemistry Products Calibrator Kit 18 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products %A1c Performance Verifiers I and II
Glycohemoglobin assay and controls Common Name
1.4 Classification Name(s)
Glycosylated hemoglobin assay: Class II (21 CFR 864.7470) Assaved Controls: Class I, reserved (21 CFR 862.1660)
1.5 Predicate device
The VITROS Chemistry Products %A1c Assay is substantially equivalent to the A1c 2.2 Plus Glycohemoglobin Assay (Tosoh Medics, Inc.).
The VITROS Chemistry Products %A1c Performance Verifiers are substantially equivalent to the VITROS Chemistry Products Performance Verifiers.
1
Device description 1.6
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
-
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products %A1c Reagent Kit, VITROS Chemistry Products Hemolyzing Reagent, VITROS Chemistry Products Calibrator Kit 18, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products %A1c Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS %A1c assay.
-
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
Device intended use 1.7
VITROS Chemistry Products %A1c Reagent Kit: For in vitro diagnostic use only. VITROS Chemistry Products %A1c Reagent Kit is used to calculate percent glycated hemoglobin (%A1c) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
VITROS Chemistry Products Calibrator Kit 18: 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).
VITROS Chemistry Products %A1c Performance Verifier I and II: For in vitro diagnostic use only. VITROS Chemistry Products %A1c Performance Verifiers are assayed controls used to monitor performance of %A1c Reagent Kit on VFTROS 5,1 FS Chemistry Systems.
Comparison to predicate device: Reagent Kit and Calibrators 1.8
The VITROS Chemistry Products %A1c Reagent Kit, VITROS Chemistry Products Calibrator Kit 18 and VITROS Chemistry Products FS Calibrator 1 are substantially equivalent to the A1c 2.2 Plus Glycohemoglobin Assay (Tosoh Medics, Inc.), which was cleared by FDA (K972265) for IVD use.
The relationship between the VITROS %A1c assay and the predicate device in NGSP units, determined by least squares linear regression, is:
VITROS %A1c assay = 1.0374 X = 0.3426 %A1c with a correlation coefficient of 0.9872, where X is the Tosoh A1c 2.2 Plus Glycohemoglobin Assay on the TOSOH Automated Glycohemoglobin Analyzer.
In addition to the above mentioned correlation study, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS %A1c assay, (refer to the VITROS Chemistry Products %A1c Reagent Kit Instructions for Use for summaries of the results of these studies).
3
The table below lists the characteristics of the VITROS %A1c Assay and the A1c 2.2 Plus Glycohemoglobin Assay (Tosoh Medics, Inc.).
| Device
Characteristic | VITROS %A1c Assay
(New device) | A1c 2.2 Plus
Glycohemoglobin Assay
(Predicate device) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To determine %A1c in
whole blood | To determine %A1c in
whole blood |
| Standardization | Traceable to both the
Diabetes Control and
Complications Trial
(DCCT) and IFCC
reference methods.
Certified by the National
Glycohemoglobin
Standardization Program
(NGSP). | Traceable to both the
Diabetes Control and
Complications Trial
(DCCT) and IFCC
reference methods.
Certified by the National
Glycohemoglobin
Standardization Program
(NGSP). |
| Basic principle | Turbidimetric inhibition
immunoassay | High performance liquid
chromatography (HPLC) |
| Reportable Range | 4 – 14 %A1c NGSP | 4 – 19 %A1c NGSP |
| Reagents | Liquid ready to use | Non-porous cation
exchange column |
| Instrumentation | VITROS 5,1 FS Chemistry
System | A1c 2.2 Plus Automated
Glycohemoglobin
Analyzer (Tosoh Medics,
Inc.) |
| Sample type | Whole blood (EDTA,
heparin, sodium
fluoride/potassium oxalate) | Whole blood (undiluted or
diluted) |
Comparison to predicate device: Performance Verifiers 1.9
:
VITROS Chemistry Products %A1c Performance Verifiers are substantially equivalent to VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use.
4
The table below lists the characteristics of the VITROS Chemistry Products %A1c Performance Verifiers and the VITROS Chemistry Products Performance Verifiers.
| Device
Characteristic | VITROS %A1c
Performance Verifiers
(New device) | VITROS Performance
Verifiers
(Predicate device) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VITROS %A1c
Performance Verifier is an
assayed control used to
monitor performance of
%A1c Reagent Kit on
VITROS 5,1 FS Chemistry
Systems. | VITROS Performance
Verifier is an assayed control
used to monitor performance
on VITROS Chemistry
Systems. |
| Matrix | A base matrix of freeze-
dried hemolysate derived
from human and ovine
blood to which surfactants,
stabilizer, and preservatives
have been added. | A base matrix of freeze-dried
human serum to which
enzymes, electrolytes,
stabilizers, preservatives and
other organic analytes have
been added. |
| Levels | Low and High | Low and High |
1.10 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products %A1c assay and the VITROS %A1c Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carey A. Mayo, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626
K041764 Re:
Trade/Device Name: VITROS Chemistry Products %A1c Reagent Kit VITROS Chemistry Products Calibrator Kit 18 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products %A1c Performance Verifiers I and II Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin assay
SEP = 9 2004
Regulatory Class: Class II Product Code: LCP, JIT, JJX Dated: June 29, 2004 Received: June 30, 2004
Dear Ms. Mayo:
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 (QS) regulation (21 CFR Part 820).
6
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 (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,
Jean M. Cooper MS, DVM.
Tean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
2.0 Indications for Use Statement
6041764
510(k) Number (if known):
Device Name:
-
- VITROS Chemistry Products %A1c Reagent Kit
-
- VITROS Chemistry Products Calibrator Kit 18
-
- VITROS Chemistry Products FS Calibrator 1
-
- VITROS Chemistry Products %A1c Performance Verifiers I and II
Indications for Use:
- For in vitro diagnostic use only. VITROS Chemistry 1. Products %A1c Reagent Kit is used to calculate percent glycated hemoglobin (%A1c) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage Alc are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
-
- & 3. 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 4. Products %A1c Performance Verifiers are assayed controls used to monitor performance of %A1c Reagent Kit on VITROS 5,1 FS Chemistry Systems.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041764
Ortho-Clinical Diagnostics, Inc.
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