(49 days)
No
The document describes a liquid calibrator product for in vitro diagnostic tests and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic product intended for the calibration of certain drug methods on a specific system, not for direct therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System." As a calibrator for in vitro diagnostic methods, it is considered an in vitro diagnostic device.
No
The device is a liquid, multi-analyte, human serum based product, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO) , Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista 10 System.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
DRUG 1 CAL is a liquid, multi-analyte, human serum based product containing digoxin, lithium, phenobarbital, phenytoin, and theophylline. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). This same product, the Dimension VistaTM System Drug 1 Calibrator (KC410), was previously cleared (K051087) for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ System. The calibrator formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day.
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
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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)
- Stability: Target shelf life for the Dimension Vista™ Drug 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the aflowable shelf life percent change should be less than or equal to:
- Digoxin: ≤ 4%.
- Phenytoin: ≤ 8 %
- Theophylline: ≤ 8 %
- Lithium: ≤ 5%
- Phenobarbital1: ≤ 8 %
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 has a stability claim of one day.
An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 31 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 0, 8 hrs, 2, 8, 32 versus freshly opened vials.
-
Traceability: The assigned values of the Drug 1 Calibrator are standardized to the enclosed table of assigned values:
- Digoxin: USP2 120000
- Phenytoin: USP 1535507
- Theophylline: USP 1653004
- Lithium: NIST SRM3 924
- Phenobarbital1: USP 1524001
-
Bottle Value Assignment:
A Master Pool is manufactured by weighing in Phenobarbital, Digoxin, Phenytoin, Lithium and Theophylline reference material into drug free normal human serum at five levels and stored frozen at -20° C.
The verification of the Master Pool assigned values are compared against previously approved Master Pool values.
The stock solution is made by adding reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified versus previously approved Master Pool values.
The commercial lot is made by adding calculated quantities of stock solution to drug free normal human serum in appropriate concentrations for two calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools.
The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates per level.
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.
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 Drug 1 Calibrator (DRUG 1 CAL - KC410)
SEP - 6 2006
A. 510(k) Number:
| B. Analytes: | Digoxin (DIG), Lithium (LI), Phenytoin (PTN), Theophylline
(THEO), and Phenobarbital (PHNO)1. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Drug 1 Calibrator (DRUG 1 CAL-KC410)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIX Calibrator, Multi-Analyte Mixture
-
- Panel: Clinical Chemistry
- G. Intended Use: The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO) , Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista 10 System.
H. Device Description:
DRUG 1 CAL is a liquid, multi-analyte, human serum based product containing digoxin, lithium, phenobarbital, phenytoin, and theophylline. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). This same product, the Dimension VistaTM System Drug 1 Calibrator (KC410), was previously cleared (K051087) for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ System. The calibrator
1 The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension Vista™ System under K051087.
1
formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day.
I. Substantial Equivalence Information:
| Device | Predicate | |
|---|---|---|
| Item | Dimension Vista™ System Drug | |
| 1 Calibrator¹ | Dimension® Drug Calibrator | |
| (K011035) | ||
| Intended | ||
| Use | The DRUG 1 CAL is an in vitro | |
| diagnostic product for the calibration | ||
| of Digoxin (DIG), Lithium (LI), | ||
| Phenobarbital (PHNO)¹, Phenytoin | ||
| (PTN) and Theophylline (THEO) | ||
| methods on the Dimension Vista™ | ||
| System. | The Drug Calibrator is an in vitro | |
| diagnostic product to be used to | ||
| calibrate the Digoxin (DGNA), Lithium | ||
| (LI), Phenobarbital (PHNO), Phenytoin | ||
| (PTN), and Theophylline (THEO) | ||
| methods on the Dimension® clinical | ||
| chemistry system. | ||
| Analytes | Digoxin (DIG), Lithium (LI), | |
| Phenytoin (PTN), Theophylline | ||
| (THEO), and Phenobarbital | ||
| (PHNO)¹. | Digoxin (DGNA), Lithium (LI), | |
| Phenobarbital (PHNO), Phenytoin | ||
| (PTN), and Theophylline (THEO). | ||
| Form | Liquid. | Liquid. |
| Traceability | DIG, PHNO, PTN, THEO – USP². | |
| LI – NIST SRM³. | DIG, PHNO, PTN, THEO – USP². | |
| LI – NIST SRM³. | ||
| Matrix | Human serum based product. | Human serum based product. |
| Number of | ||
| Levels | Two levels. | Five levels. |
The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension Vista™ System under K051087.
2 USP - United States Pharmacopeia.
3 NIST SRM - National Institute of Standards and Technology Standard Reference Material.
J. Standard/Guidance Document Referenced:
-
- 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
-
- 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™ Drug 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of
2
the product stored at 4℃ with control stored at -20℃. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the aflowable shelf life percent change should be less than or equal to:
| Analyte | Allowable Shelf life
percent change |
|----------------|----------------------------------------|
| Digoxin | ≤ 4%. |
| Phenytoin | ≤ 8 % |
| Theophylline | ≤ 8 % |
| Lithium | ≤ 5% |
| Phenobarbital1 | ≤ 8 % |
T The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension VistaTM System under K051087.
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 has a stability claim of one day.
An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 31 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 0, 8 hrs, 2, 8, 32 versus freshly opened vials.
-
- Traceability: The assigned values of the Drug 1 Calibrator are standardized to the enclosed table of assigned values:
| Analyte | Reference Material |
|---|---|
| Digoxin | USP2 120000 |
| Phenytoin | USP 1535507 |
| Theophylline | USP 1653004 |
| Lithium | NIST SRM3 924 |
| Phenobarbital1 | USP 1524001 |
The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension VistaTM System under K051087
2 United States Pharmacopeia.
3 National Institute of Standards and Technology - Standard Reference Material.
-
- Bottle Value Assignment:
A Master Pool is manufactured by weighing in Phenobarbital, Digoxin, Phenytoin, Lithium and Theophylline reference material into drug free normal human serum at five levels and stored frozen at -20° C.
- Bottle Value Assignment:
3
The verification of the Master Pool assigned values are compared against previously approved Master Pool values.
The stock solution is made by adding reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified versus previously approved Master Pool values.
The commercial lot is made by adding calculated quantities of stock solution to drug free normal human serum in appropriate concentrations for two calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools.
The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates per level.
t
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc P.O. Box 6101, Mail Stop 514 Newark, DE, 19714-6101
SEP - 6 2006
Re: K062034
Trade/Device Name: Dimension Vista™ Drug 1 Calibrator (KC410) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 18, 2006 Received: July 19, 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).
Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutié
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): Kd6203
Device Name:
Dimension Vista™ Drug 1 Calibrator (KC410)
Indications for Usc:
The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods 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)
Carole Benson
Division Sign-Off
Office of in Vitro Dlagnostic Device Evaluation and Safety
510(k) K062034