(49 days)
Not Found
No
The summary describes a calibrator for a clinical chemistry system, focusing on standard laboratory procedures like stability testing, traceability, and value assignment. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic product used to calibrate a clinical chemistry system, not to treat or prevent a disease or condition.
No
The document describes a calibrator, which is a product used to calibrate a diagnostic device, not a diagnostic device itself.
No
The device description explicitly states it is a liquid bovine serum albumin-based product, indicating it 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 Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Product codes (comma separated list FDA assigned to the subject device)
JIS
Device Description
The high sensitivity C-reactive protein Calibrator is a liquid bovine serum albumin-based product. Levels 2 -5 contain a human C-reactive protein.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Stability
Calibrator shelf life is determined by comparing results of the product stored at 4°C with product stored at -70°C to ensure that analytical system drift is dissociated with calibrator drift. Linear regression across the shelf life interval for each test sample versus test day will have non-significant slopes (p> 0.05) or observed drift within +/-5% for non-zero samples and +/-0.05 mg/L at 0 mg/L CRP over a 12 month interval The shelf life of the product will be 6 months after the successful completion of 7 months of real time stability on three lots of product. -
Traceability:
The assigned values of the CCRP calibrator are standardized to the International Federation of Clinical Chemistry (IFCC) International Reference Preparation for Plasma Proteins, the Community Bureau of Reference (BCR) and the College of American Pathologists (CAP). The basis of this international standardization is the IFCC/BCR/CAP reference preparation for 14 human serum proteins (Lot No. 91/0619=CRM470=RPPHS 91/0619) (lot V). -
Value Assignment
Three Dimension® clinical chemistry analyzers are calibrated with the approved CCRP Masterpool. The acceptable recovery of an approved CCRP Calibrator lot must be obtained. Test calibrator levels are then tested on three separate analyzers with different CCRP flex lots. The grand mean of all 5 replicate test means of all 9 curves is the value assignment for each Calibrator Level.
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.
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DEC 2 3 2005
Page 1 of 4
510(k) Summary for the Dimension® CardioPhase® high sensitivity CRP Calibrator (CCRP Calibrator - RC434)
A. 510(k) Number:
B. Analyte: C-Reactive Protien Calibrator
C. Type of Test: Calibrator Material
D. Applicant:
Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager (302) 631-9454
E. Proprietary and Established Names: Dimension® CardioPhase® high sensitivity CRP Calibrator (CCRP Calibrator- RC434)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 CALIBRATOR
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- Classification: Class II
-
- Product Code: JIS CALIBRATORS, PRIMARY
-
- Panel: CLINICAL CHEMISTRY
G. Intended Use:
- Intended use(s):
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
2. Indication(s) for use:
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
1
-
- Special condition for use statement(s): none
-
- Special instrument Requirements: none
H. Device Description:
The high sensitivity C-reactive protein Calibrator is a liquid bovine serum albumin-based product. Levels 2 -5 contain a human C-reactive protein.
I. Substantial Equivalence Information:
-
- Predicate device name(s): N Rheumatology Standard SL on the BN Systems.
-
- Predicate K number(s): K964527
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Device | |
| Dimension® CardioPhase® | ||
| (CCRP) Calibrator | Predicate | |
| N Rheumatology Standard | ||
| SL | ||
| Intended Use | The Dimension® CCRP | |
| Calibrator is an in vitro | ||
| diagnostic product intended to | ||
| be used to calibrate the | ||
| Dimension® CardioPhase® | ||
| high sensitivity C-reactive | ||
| protein method for the | ||
| Dimension® clinical chemistry | ||
| system with the heterogeneous | ||
| immunoassay module. | Establishment of reference | |
| curves for the | ||
| immunonephelometric | ||
| determination of rheumatoid | ||
| factors (RF), anti-streptolysin | ||
| O (ASL) and C-reactive | ||
| protein (CRP) using the BN | ||
| Systems. | ||
| Traceability | IFCC/BCR/CAP | |
| CRM 470 | IFCC/BCR/CAP | |
| CRM 470 |
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| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Dimension® CardioPhase® | ||
| hsCRP (CCRP) Calibrator | N Rheumatology Standard | |
| SL | ||
| Matrix | liquid bovine serum albumin- | |
| based | human sera based | |
| Number of levels | Multi-Point | |
| 5 levels provided | Multi-Point | |
| 1 level provided | ||
| (instrument prepares | ||
| 6 standard dilutions) | ||
| Reference Curve | ||
| Fit Calculation | Logit | 4 Parameter Logit Log |
J. Standard/Guidance Document Referenced:
1. Guidance;
Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays Document issued on: September 22, 2005
| 2. Standards; | |
|---|---|
| GP22-A | Continuous Quality Improvement Essential Management Approaches |
| CEN 13640 | Stability testing of In-Vitro Diagnostic Devices |
| ISO 14971:2000 | Medical devices -Application of risk management to medical |
| devices | |
| ISO 15223 | Medical devices - Symbols to be used with medical device labeling |
| and information to be supplied |
K. Test Principle:
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RF434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. The hsCRP method is a one step enzyme immunoassay based on the "sandwich" principle.
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L. Performance Characteristics:
1. Stability
Calibrator shelf life is determined by comparing results of the product stored at 4°C with product stored at -70°C to ensure that analytical system drift is dissociated with calibrator drift. Linear regression across the shelf life interval for each test sample versus test day will have non-significant slopes (p> 0.05) or observed drift within +/-5% for non-zero samples and +/-0.05 mg/L at 0 mg/L CRP over a 12 month interval The shelf life of the product will be 6 months after the successful completion of 7 months of real time stability on three lots of product.
2. Traceability:
The assigned values of the CCRP calibrator are standardized to the International Federation of Clinical Chemistry (IFCC) International Reference Preparation for Plasma Proteins, the Community Bureau of Reference (BCR) and the College of American Pathologists (CAP). The basis of this international standardization is the IFCC/BCR/CAP reference preparation for 14 human serum proteins (Lot No. 91/0619=CRM470=RPPHS 91/0619) (lot V).
3. Value Assignment
Three Dimension® clinical chemistry analyzers are calibrated with the approved CCRP Masterpool. The acceptable recovery of an approved CCRP Calibrator lot must be obtained. Test calibrator levels are then tested on three separate analyzers with different CCRP flex lots. The grand mean of all 5 replicate test means of all 9 curves is the value assignment for each Calibrator Level.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and tail feathers.
DEC 2 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Business Community PO Box 6101, Building 500 Newark, DE 19714-6101
Re: K053104
K033104
Trade/Device Name: Dimension® CardioPhase® high sensitivity C-reactive protein Calibrator (CCRP Calibrator -RC434) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: November 2, 2005 Received: November 4, 2005
Dear Ms. Tasker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession 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 r ou may, thereforey isions 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) This letter will anow you to begin maxions of sybstantial equivalence of your device to a legally premation notification "Te 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 you desire specific mostion and advertising of your device, please contact the Office of In or quotions on the program and Safety at (240) 276-0484. Also, please note the v Itto Diagnoutied, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may other generational 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 G
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): K053104
Device Name:
Dimension® CardloPhase® high sensitivity C-reactive protein Calibrator (CCRP Calibrator - RC434)
Indications for Use:
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RF434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Ann Chappie
Division
Office of in Vier Tingnoma ರಿಕಾರಿ ಕಾರದಿಂದರೆಯ ಮನೆ ಕಿಡ್ಡೆತಿ /
510(k) K053104
× Prescription Use (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)