(28 days)
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No
The document describes a calibrator kit for in vitro diagnostic use and does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is described as a calibrator kit for in vitro diagnostic use, meaning it's used to calibrate laboratory instruments for measuring substances in patient samples, not to treat a patient directly.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only."
No
The device description clearly states that the device is a "Calibrator Kit" containing lyophilized products prepared from bovine serum, vials, and diluents. This indicates a physical, in vitro diagnostic product, not a software-only device.
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 the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
Furthermore, the description of the device as a "Calibrator Kit" used to "calibrate VITROS® Chemistry Systems for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH and LIPA" confirms its role in the diagnostic process by ensuring the accuracy of tests performed on patient samples.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
VITROS® Calibrator Kit 3 contains three levels of calibrators: Calibrator 1, 2, and 3. The calibrators are lyophilized, multi-analyte products prepared from processed bovine serum to which enzymes, electrolytes, stabilizers, and preservatives have been added. VITROS Chemistry Products Calibrator Kit 3 contains four vials each of lyophilized calibrator 1, 2, and 3 and four vials each of calibrator diluent 1, 2, and 3.
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
For prescription use only.
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)
Real-time stability studies for shelf-life and open-vial claims have been conducted and acceptance criteria were met. VITROS Chemistry Products Calibrator Kit 3 is to be stored frozen at less than or equal to -18℃ for 24 months or until the expiration date printed on each carton. Real-time stability studies for shelf-life are on- going. The final shelf life claims will be based on the completed real-time study results. Reconstituted products should be used immediately or stored refrigerated at 2-8°C for less than or equal to 24 hours.
Values assigned to the VITROS Chemistry Products Calibrator Kit 3 for lactate dehydrogenase LDHI Slides are traceable to the IFCC recommended reference method as described in IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 C. Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase .1
The process by which Supplementary Assigned Values (SAV) are assigned to VITROS Chemistry Products Calibrator Kit 3 is analogous to the value transfer process described by Broughton and Eldjarn (P.M.G. Broughton and L. Eldjarn, Methods of assigning accurate values to reference serum, Part 1. The use of reference laboratories and consensus values, with an evaluation of a procedure transferring values from one reference serum to another, Ann. Clin. Biochem. 22: 625-634, 1985). The major difference is that instead of transferring values from one serum pool to another, reference method values are transferred to product calibrator fluids, using a panel of human samples as an intermediate Working Calibrator.
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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them, possibly representing interconnectedness or health services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE HANNA SENIOR REGULATORY AFFAIRS MANAGER 100 INDIGO CREEK DRIVE ROCHESTER, NY 14626-5101
Re: K161140
Trade/Device Name: VITROS Chemistry Products Calibrator Kit 3 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, multi-analyte mixture Regulatory Class: II Product Code: JIX Dated: April 21, 2016 Received: April 22, 2016
Dear Marlene Hanna:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Katherine Serrano -S
: Court
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161140
Device Name
VITROS® Chemistry Products Calibrator Kit 3
Indications for Use (Describe)
For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness for the
VITROS® Chemistry Calibrator Kit 3
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.
-
- 510(k) Number: K161140
2. Applicant:
| Contact: | Marlene A. Hanna, RAC
Sr. Regulatory Affairs Manager |
|----------|-----------------------------------------------------------------------------------|
| Address: | Ortho Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14506 |
| Phone: | (585) 453-4041
(585) 453-3368 (Facsimile) |
-
- Date: April 21, 2016
4. Proprietary and Established Names:
VITROS® Chemistry Products Calibrator Kit 3
5. Regulatory Information:
Regulation section: 21 CFR §862.1150, calibrator, multi-analyte mixture Classification: Class II Product Code: JIX Panel: Clinical Chemistry
6. Purpose of the 510(k) Submission:
The VITROS® Chemistry Products Calibrator Kit 3 is being modified by addition of nominal values and information to support traceability of lactate dehydrogenase (LDH) to the IFCC/L->P method and removal of value-assignment information for acid phosphatase (ACP). The VITROS ACP assay is no longer commercially available. There are no changes made to the other analytes (ALT, ALKP, AMYL, AST, CK, GGT and LIPA) the calibrator kit is used with.
7. Predicate Device:
Device Name: VITROS® Chemistry Products Calibrator Kit 3 510(k) Number: K001679 Manufacturer: Ortho-Clinical Diagnostics, Inc.
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8. Intended Use:
See Indications for Use
9. Indications for Use:
For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS® 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH and LIPA.
Special Conditions for Use Statement(s): For prescription use only.
10. Device Description:
VITROS® Calibrator Kit 3 contains three levels of calibrators: Calibrator 1, 2, and 3. The calibrators are lyophilized, multi-analyte products prepared from processed bovine serum to which enzymes, electrolytes, stabilizers, and preservatives have been added. VITROS Chemistry Products Calibrator Kit 3 contains four vials each of lyophilized calibrator 1, 2, and 3 and four vials each of calibrator diluent 1, 2, and 3.
11. Test Principle:
VITROS® Chemistry Products Calibrator Kit 3 is intended for in vitro diagnostic use in the calibration of ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA on VITROS® Chemistry and Integrated Systems.
12. Substantial Equivalence Information:
VITROS® Chemistry Products Calibrator Kit 3 Predicate device name: Predicate K number: K001679 Comparison with Predicate: Please see Table 1 below for Similarities and differences for the VITROS Calibrator Kit 3.
| SIMILARITIES | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Intended Use | For in vitro diagnostic use only. | |
| VITROS® Chemistry Products | ||
| Calibrator Kit 3 is used to calibrate | ||
| VITROS® 250/350/5,1 FS and 4600 | ||
| Chemistry Systems and the VITROS | ||
| 5600 Integrated System for the | ||
| quantitative measurement of ALT, | ||
| ALKP, AMYL, AST, CK, GGT, | ||
| LDH and LIPA. | Same | |
| SIMILARITIES | ||
| Item | New Device | Predicate Device |
| Measured | ||
| Analytes (Value assigned) | Alanine Aminotransferase (ALT) | |
| Alkaline Phosphatase (ALKP) | ||
| Amylase (AMYL) | ||
| Aspartate Aminotransferase (AST) | ||
| Creatine Kinase (CK) | ||
| Gamma Glutamyltransferase (GGT) | ||
| Lactate Dehydrogenase (LDH) | ||
| Lipase (LIPA) | Same | |
| Form | Lyophilized | Same |
| Analyte Source | ALT: Porcine Heart | |
| ALKP: Porcine Kidney | ||
| AMYL: Porcine Pancreas | ||
| AST: Porcine Heart | ||
| CK: Porcine Heart | ||
| GGT: Porcine Kidney | ||
| LDH: Chicken Heart | ||
| LIPA: Porcine Pancreas | Same | |
| Number of Levels | Three | Same |
| Target | ||
| Concentrations | ||
| (U/L) | ALT: 20, 250, 900 | |
| ALKP: 20, 150, 1450 | ||
| AMYL: 35, 360, 1000 | ||
| AST: 11, 243, 775 | ||
| CK: 40, 700, 1650 | ||
| GGT: 25, 125, 1360 | ||
| LIPA: 30, 200, 1950 | Same | |
| Stability | Unopened: Frozen: ≤ -18 °C (L/37 °C | |
| LDHI | IFCC/L->P/37 °C | |
| LIPA | pH Stat |
The assigned values of the VITROS Calibrator Kit 3 are traceable as listed in the following table:
Refer to the below table for representative target concentrations for LDH in VITROS Calibrator Kit 3.
| VITROS Calibrator
Kit 3 | Nominal Calibrator Value
LDH (U/L) |
|----------------------------|---------------------------------------|
| Calibrator Vial 1 | 90 |
| Calibrator Vial 2 | 320 |
| Calibrator Vial 3 | 800 |
16. Conclusions
Based on the testing and the comparisons with the predicate device, the VITROS Calibrator Kit 3 (Modified) is substantially equivalent to the VITROS Calibrator Kit 3 cleared under K001679.