(24 days)
Not Found
No
The device is a calibrator for an in vitro diagnostic test and the description focuses on its chemical composition, stability, and value assignment process, with no mention of AI or ML.
No
The device is described as an "in vitro diagnostic product for the calibration of Creatine Kinase (CK) method." It is used to ensure the accuracy of a diagnostic test, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The CK CAL is an in vitro diagnostic product".
No
The device is a physical in vitro diagnostic product (calibrator) consisting of frozen liquid in vials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The CK CAL is an in vitro diagnostic product for the calibration of Creatine Kinase (CK) method on the Dimension Vista™ System."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The CK CAL is an in vitro diagnostic product for the calibration of Creatine Kinase (CK) method on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
CK CAL is frozen, liquid, bovine serum albumin based product containing creatine kinase from porcine heart. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B. The volume per vial is 1.0 mL.
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)
- Stability: Target shelf life for the Dimension Vista™ Creatine Kinase Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70℃. The method is calibrated from this stored material. The -20°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be ≤ 5 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.
A vial punctured by the instrument and stored on board is stable for seven days.
An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days.
For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 1, 8, 15, 22, and 32 versus freshly opened vials. - Traceability: The assigned values of the Creatine Kinase Calibrator are traceable to Master Pool, Dimension® clinical chemistry system.
- Value Assignment:
The new calibrator Master Pool is made by gravimetrically adding quantities of creatine kinase to bovine serum albumin base to target concentrations. The concentrations are verified against a previously approved Master Pool lot. The final bottle value for the Master Pool is assigned for each level by testing N = 45 replicates on multiple instruments.
A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding quantities of creatine kinase to bovine serum albumin base to target concentrations. The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values.
For the commercial calibrator lot, calculated quantities of the stock solution are added to the bovine serum albumin base to target concentrations. The concentration of each level is verified to be within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to each level and verified using a released commercial lot of calibrator on multiple instruments for N = 45 total replicates.
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.
Not Found
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
§ 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.
0
510(k) Summary for the Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340)
A. 510(k) Number:
!JUL 1 0 2006
| B. Analyte: | Creatine Kinase (CK). |
|---|---|
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 |
| Victor M. Carrio, Regulatory Affairs and Compliance Manager | |
| Office: (302) 631-0376 Fax: (302) 631-6299 |
E. Proprietary and Established Names:
Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIT Calibrator, Secondary
-
- Panel: Clinical Chemistry
- The CK CAL is an in vitro diagnostic product for the calibration of G. Intended Use: Creatine Kinase (CK) method on the Dimension Vista™ System.
H. Device Description:
CK CAL is frozen, liquid, bovine serum albumin based product containing creatine kinase from porcine heart. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B. The volume per vial is 1.0 mL.
I. Substantial Equivalence Information:
- Predicate Device: Dimension® Creatine KinaseVerifier (DC26) and VITROSTM Chemistry Products Calibrator Kit 3.
1
- Predicate K Number(s): K861700 for Dimension® clinical chemistry system. For the Ortho-Diagnostics VITROS Calibrator Kit 3, a 510(k) was not aveillable.
| Comparison | ||||
|---|---|---|---|---|
| Item | Dimension Vista™ | |||
| System Creatine | ||||
| Kinase Calibrator | Dimension® | |||
| Creatine Kinase | ||||
| Verifier | Otho-Clinical | |||
| Diagnostics | ||||
| VITROSTM | ||||
| Calibrator Kit 3 | ||||
| Intended Use | The CK CAL is an in vitro | |||
| diagnostic product for the | ||||
| calibration of the creatine | ||||
| kinase (CK) method on the | ||||
| Dimension Vista™ | ||||
| System. | The Dimension® Creatine | |||
| Kinase Verifier is an in | ||||
| vitro diagnostic product to | ||||
| be used to verify the | ||||
| Dimension® clinical | ||||
| chemistry systems for the | ||||
| Creatine Kinase (CK) | ||||
| method. | For in vitro diagnostic use | |||
| onlv. | ||||
| VITROS Calibrator Kit 3 is | ||||
| intended for use in | ||||
| calibration of the VITROS | ||||
| Chemistry Systems for the | ||||
| quantitative measurement | ||||
| of AcP, ALKP, ALT, AST, | ||||
| CK, GGT, LDH and LIPA. | ||||
| Analytes | Creatine Kinase | Creatine Kinase | Acid Phosphatase (AcP), | |
| alanine aminotransferase | ||||
| (ALT), alkaline | ||||
| aminotransferase (ALKP), | ||||
| amylase (AMYL), aspartate | ||||
| aminotransferase (AST), | ||||
| creatine kinase (CK), | ||||
| gamma glutamyltransferase | ||||
| (GGT), lactate | ||||
| dehydrogenase (LDH) and | ||||
| lipase (LIPA). | ||||
| Form | Liquid | Lyophilized | Lyophilized | |
| Traceability | Master Pool, Dimension® | |||
| clinical chemistry system | ||||
| values. | Master Pool, Dimension® | |||
| clinical chemistry system | ||||
| values. | Values assigned to | |||
| VITROS Chemistry | ||||
| Product Calibrator Kit 3 are | ||||
| traceable to high quality | ||||
| materials. | ||||
| Matrix | Bovine serum albumin | |||
| based product containing | ||||
| creatine kinase from | ||||
| porcine heart. | Human serum base | |||
| product containing creatine | ||||
| kinase from simian heart. | Bovine serum and porcine | |||
| heart based product. | ||||
| Levels | Two levels. | Three levels. | Three levels. |
-
- Comparison with Predicate:
J. Standard/Guidance Document Referenced:
- l. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999 Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004
2
-
- Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices
K. Performance Characteristics:
-
- Stability: Target shelf life for the Dimension Vista™ Creatine Kinase Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70℃. The method is calibrated from this stored material. The -20°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be ≤ 5 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.
A vial punctured by the instrument and stored on board is stable for seven days.
- Stability: Target shelf life for the Dimension Vista™ Creatine Kinase Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70℃. The method is calibrated from this stored material. The -20°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be ≤ 5 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.
An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days.
For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 1, 8, 15, 22, and 32 versus freshly opened vials.
-
- Traceability: The assigned values of the Creatine Kinase Calibrator are traceable to Master Pool, Dimension® clinical chemistry system.
-
- Value Assignment:
The new calibrator Master Pool is made by gravimetrically adding quantities of creatine kinase to bovine serum albumin base to target concentrations. The concentrations are verified against a previously approved Master Pool lot. The final bottle value for the Master Pool is assigned for each level by testing N = 45 replicates on multiple instruments.
A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding quantities of creatine kinase to bovine serum albumin base to target concentrations. The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values.
For the commercial calibrator lot, calculated quantities of the stock solution are added to the bovine serum albumin base to target concentrations. The concentration of each level is verified to be
3
within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to each level and verified using a released commercial lot of calibrator on multiple instruments for N = 45 total replicates.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 0 2006
Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. 500 GBC Drive PO Box 6101, M/S 514 Newark, DE 19714-6101
Re: K061702
Trade/Device Name: Dimension Vista™ Creatine Kinase Calibrator (CK Calibrator, KC340) Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 15, 2006 Received: June 16, 2006
Dear Mr. Carrio:
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).
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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, perceits 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 tolloffree mber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto G. A
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
6
Indications For Use Statement
510(k) Number (if known):
Device Name:
Dimension VistaTM Creatine Kinase Calibrator (CK Calibrator , KC340)
Indications for Use:
The CK CAL is an in vitro diagnostic product for the calibration of Creatine Kinase (CK) method on the Dimension Vista™ System.
Prescription Use X ............................................................................................................................................................................ (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-counter Use (21 CFR 801 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)
Carol Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety