(53 days)
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM System
CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. 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). The volume per vial is 2.5 mL.
The provided document includes a section on "Performance Characteristics" specifically addressing the stability of the Dimension Vista™ System Chemistry 1 Calibrator. This section details the acceptance criteria for shelf-life stability and reports on how the device meets these criteria through a specific study design.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Analyte | Acceptance Criteria (Allowable Shelf life % change) | Reported Device Performance (Implied) |
|---|---|---|
| Urea Nitrogen | ≤ 5% | The study indicates that the "percent change over time is determined where the allowable shelf life percent change should be less than or equal to" these specified percentages. The subsequent statement, "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.", implies that the real-time data met or surpassed these acceptance criteria for the assigned 12-month shelf life. |
| Calcium | ≤ 5 % | |
| Cholesterol | ≤ 3% | |
| Creatinine | ≤ 5% | |
| Glucose | ≤ 5% | |
| Lactic Acid | ≤ 5% | |
| Magnesium | ≤ 3% | |
| Thyroxine | ≤ 6% | |
| Thyroxine Uptake | ≤ 6% | |
| Uric Acid | ≤ 5% |
The document also specifies acceptance criteria for on-board and open-vial stability:
- On-board stability: One day.
- Open vial (recapped and refrigerated): 30 days.
The reported performance for these is implied by the statement "A vial punctured by the instrument and stored on board has a stability claim of one day" and "An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 30 days." This suggests that testing was conducted and demonstrated compliance with these claims.
Study Proving Device Meets Acceptance Criteria:
The study described is a shelf-life stability study for the Dimension Vista™ Chemistry 1 Calibrator.
- Study Design/Methodology:
- Objective: To determine the target shelf life (12 months) of the calibrator and validate its stability under various conditions (long-term storage, on-board, and open-vial).
- Long-Term Shelf Life: Results of the product stored at 4°C are compared with a control stored at -20°C. The method is calibrated using the -20°C stored material, and the 4°C material values are recovered against this calibration. The percent change over time is monitored against the allowable shelf-life percent change criteria for each analyte. "Real-time data on file at Dade Behring, Inc." is used for the final shelf-life assignment.
- On-Board and Open-Vial Stability: Vials are opened/punctured on day zero. A sufficient quantity for multiple calibrations is removed. The vials are then recapped and stored at 2-8°C. These opened/punctured vials are tested on days 0, 8 hours, 2, 8, and 31, and their performance is compared against freshly opened vials.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of individual calibrator vials or batches used in the stability studies. For bottle value assignment, it mentions "N = 45 replicates" tested using multiple instruments. This refers to the assignment of final values to commercial lots, which is a part of quality control and verification, but not necessarily the sample size for the long-term stability testing itself. The sample size for the stability portion is not precisely quantified in the provided text, but it implies a longitudinal study over time.
- Data Provenance: The document does not specify the country of origin of the data. The study is prospective in nature, as it involves monitoring the performance of the calibrator over time under controlled storage conditions to establish shelf life and stability claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is Not Applicable in this context. The device is a calibrator, and its performance (stability and value assignment) is assessed against analytical standards and reference materials (traceability to NIST SRMs, USP, CDC Abell-Kendall method), rather than expert interpretation of results on patient samples.
4. Adjudication Method for the Test Set
This information is Not Applicable. As the ground truth is based on analytical standards and reference methods, there is no need for expert adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is Not Applicable. No MRMC study was done, as this is a calibrator for an in vitro diagnostic chemistry system, not an imaging or diagnostic algorithm requiring human reader interpretation or comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is Not Applicable in the typical sense of an "algorithm." The calibrator itself is a physical product. Its performance is evaluated through a standalone stability study, where the calibrator's values are measured by instruments and compared against established analytical criteria, without human intervention in the result generation itself beyond the operation of the instrument and data analysis.
7. Type of Ground Truth Used
The ground truth for the performance (stability and value assignment) of the calibrator is based on:
- Analytical Standards and Reference Materials: Traceability to various certified reference materials such as:
- NIST SRM (National Institute of Standards and Technology - Standard Reference Material) for BUN, CA, CREA, GLU, MG, URCA, CHOL.
- CDC (Centers for Disease Control) Abell-Kendall reference method for CHOL.
- Lactic acid – lithium salt A-Grade for LA.
- USP (United States Pharmacopeia) for T4.
- Calculated Value: For TU.
- Previously Approved Master Pool/Standard Values: Used for verification of Master Pool/Standard values and stock solution values.
8. Sample Size for the Training Set
This information is Not Applicable. This product is a calibrator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the calibrator is its manufacturing process to meet specific constituent concentrations, verified against reference materials.
9. How the Ground Truth for the Training Set Was Established
This information is Not Applicable. As above, there is no "training set." The "ground truth" for the calibrator's composition and assigned values is established through gravimetric additions of reference materials to stock solutions and base matrices, followed by verification against primary standard materials, Master Pools, and previously approved Master Pool/Standard values, all traceable to the analytical standards listed in point 7. The final bottle values are assigned and verified by testing 45 replicates on multiple instruments against these established standards.
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510(k) Summary for the Dimension Vista™ System Chemistry 1 Calibrator (CHEM 1 CAL - KC110)
A. 510(k) Number:
B. Analytes:
Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN)4 and Uric Acid (URCA).
AUG 2 1 2006
- 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 Chemistry 1 Calibrator (CHEM 1 CAL-KC110)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIX Calibrator, Multi-Analyte Mixture
-
- Panel: Clinical Chemistry
H. Device Description:
CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose.
G. Intended Use: The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) 1 and Uric Acid (URCA) methods on the Dimension Vista™ System.
1 The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.
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lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. 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). The volume per vial is 2.5 mL. This same product, the Dimension Vista™ System Chemistry 1 Calibrator (KC110), was previously cleared (K051087) for the calibration of the Blood Urea Nitrogen (BUN) method on the Dimension Vista™ system.
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ostantial Equivalence Informatio I
| Item | Device | Predicate Devices | ||||
|---|---|---|---|---|---|---|
| IntendedUse | Dimension Vista™System Chemistry 1Calibrator² | CHEM ICalibratorK860021(URCA-K862359) | Chemistry IICalibratorK861700 | CholesterolCalibratorK861700 | ThyroxineCalibratorK862359 | Thyronine UptakeCalibratorK862359 |
| The CHEM 1 CAL is anin vitro diagnosticproduct for the calibrationof Calcium (CA),Cholesterol (CHOL),Creatinine (CREA),Glucose (GLU), LacticAcid (LA), Magnesium(MG), Thyroxine (T4),Thyronine Uptake (TU),Blood Urea Nitrogen(BUN)² and Uric Acid(URCA) methods on theDimension Vista™System. | The Dimension®Chemistry ICalibrator is an invitro diagnosticproduct to be used tocalibrate theDimension® clinicalchemistry system forthe Calcium (CA),Creatinine (CREA),Glucose(GLU/GLUC), LacticAcid (LA), UreaNitrogen (BUN) andUric Acid (URCA)methods. | CHEM II Calibratoris an in vitrodiagnostic product tobe used to calibratethe Dimension®clinical chemistrysystem for themagnesium (MG),phosphorus (PHOS)and triglycerides(TRIG) methods. | The Dimension®Cholesterol Calibratoris an in vitrodiagnostic product tobe used to calibrate theDimension® clinicalchemistry system forthe Cholesterol(CHOL) method. | The Dimension®Thyroxine Calibratoris an in vitrodiagnostic product tobe used to calibrate theDimension® clinicalchemistry system forthe Thyroxine (T4)method. | The Dimension®Thyronine Uptake isan in vitro diagnosticproduct to be used tocalibrate theDimension® clinicalchemistry system forthe Thyronine Uptakemethod. | |
| Analytes | Calcium (CA),Cholesterol (CHOL),Creatinine (CREA),Glucose (GLU), LacticAcid (LA), Magnesium(MG), Thyroxine (T4),Thyronine Uptake (TU),Blood Urea Nitrogen(BUN)² and Uric Acid(URCA) | Calcium (CA),Creatinine (CREA),Glucose (GLU),Lactic Acid (LA),Urea Nitrogen (BUN)and Uric Acid(URCA). | Magnesium (MG). | Cholesterol (CHOL). | Thyroxyne (T4). | Thyronine Uptake(TU). |
| Item | Device | Predicate Devices | ||||
| Dimension Vista™System Chemistry 1Calibrator² | CHEM ICalibratorK860021(URCA–K862359) | Chemistry IICalibratorK861700 | CholesterolCalibratorK861700 | ThyroxineCalibratorK862359 | Thyronine UptakeCalibratorK862359 | |
| Form | Liquid. | Lyophilized. | Liquid. | Lyophilized. | Lyophilized. | Lyophilized. |
| Traceability | BUN – NIST SRM 912²CA – NIST SRM 915.CHOL – Abell-Kendall(CDC-NCEP).CREA – NIST SRM 914.GLU – NIST SRM 917.LA – Lactic acid – lithiumsalt A-Grade.MG – NIST SRM 929A.T4 – USP.TU – Calculated value.URCA – NIST SRM 913. | BUN – NIST SRM912CA – NIST SRM 915.CREA – NIST SRM914.GLU – NIST SRM917.LA – Lactic acid –lithium salt A-Grade.URCA – NIST SRM913. | MG – NIST SRM929A. | CHOL – NIST SRM911. | T4 – Thyroxine MasterPool. | TU – ThyronineUptake Master Pool. |
| Matrix | Bovine serum albuminbased product. | Bovine serumalbumin basedproduct. | Pure magnesiumdissolved in a dilutesolution of HCL,reagent gradepotassiumdihydrogenphosphate andreagent gradeglycerol. | Bovine serum albuminbased product. | Human serum basedproduct. | Human serum basedproduct. |
| Number ofLevels | Two levels. | Three levels. | Three levels. | Three levels. | Five levels. | Five levels. |
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² The Dinansion Vista™ System Chemistry 1 Calbrator was previously cleared for the calbration of blood ura nimogen (BUN) in the Dimension Vista™ System
under K051087.
.
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J. Standard/Guidance Document Referenced:
| 1. Guidance: | Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Diagnostic Calibrators; Final, 02/22/1999Guidance for Industry and FDA Staff - Use of Symbols on Labelsand in Labeling of In Vitro Diagnostic Devices Intended forProfessional Use, 11/30/2004 |
|---|---|
| 2. Standards: | CEN 13640 Stability testing of In-Vitro Diagnostic DevicesISO 14971:2000 Medical devices -Application of risk management tomedical devices |
K. Performance Characteristics:
-
- Stability: Target shelf life for the Dimension Vista™ Chemistry 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°C. 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 allowable shelf life percent change should be less than or equal to:
| Analyte | Allowable Shelf life percent change |
|---|---|
| Urea Nitrogen3 | ≤ 5%. |
| Calcium | ≤ 5 % |
| Cholesterol | ≤ 3% |
| Creatinine | ≤ 5% |
| Glucose | ≤ 5% |
| Lactic Acid | ≤ 5% |
| Magnesium | ≤ 3% |
| Thyroxine | ≤ 6% |
| Thyroxine Uptake | ≤ 6% |
| Uric Acid | ≤ 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 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 30 days.
For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are
3 The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.
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recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 0, 8 hrs, 2, 8, 31 versus freshly opened vials.
- The assigned values of the Chemistry 1 Calibrator are standardized 2. Traceability: to the enclosed table of assigned values:
| Constituent | Traceability |
|---|---|
| BUN4 | NIST SRMa 912 |
| CA | NIST SRM 915 |
| CHOL | NIST SRM 911(CDCb) Abell-Kendall reference method |
| CREA | NIST SRM 914 |
| GLU | NIST SRM 917 |
| LA | Lactic acid- lithium salt (A- Grade) |
| MG | NIST SRM 929 A |
| T4 | USPc |
| TU | Calculated value |
| URCA | NIST SRM 913 |
4 National Institute of Standards and Technology - Standard Reference Material. 6 Centers for Disease Control.
C United States Pharmacopeia.
-
- Bottle Value Assignment:
Urea Nitrogen, calcium carbonate, creatinine, cholesterol. glucose, lactic acid, magnesium gluconate, uric acid, and thyroxine reference materials are weighed appropriate aqueous solutions or human serum traced to primary standard material. Master Pool and standards are stored frozen for each analyte. The verification of the Master Pool/Standard values are compared against previously approved Master Pool/Standard 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/Standard values. The commercial lot is made by adding calculated quantities of stock solution to base matrix 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.
- Bottle Value Assignment:
4 The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor M. Carrio RA/OS Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101
AUG 2 1 2006
Re: K061838
Trade/Device Name: Dimension Vista™ Chemistry 1 Calibrator (KC110) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 28, 2006 Received: June 29, 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, 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 yours,
Alberto Guts
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
510(k) Number (if known): K061838
Device Name:
Dimension Vista™ Chemistry 1 Calibrator (KC110)
Indications for Use:
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM 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)
Carl Benson
Division Sign-Off
Division Sign-On
ce of In Vitro Diagnost Evaluation and Safety
510(k) K061838
§ 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.