(104 days)
The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® clinical chemistry system Cyclosporine Fr, it® 2000 Cyclosporine Specific Assay.
The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of one vial of each calibrator level 0-5. The target concentrations of the calibrator levels are approximately 0, 200, 400, 800, 1400 and 2000 ng/mL of cyclosporine. Level 0 is used for dilution of over-range samples (>2000 ng/mL) in order to obtain Lover o lood for analyange; it is not used in calibration. Levels 1 through 5 are used for calibration of the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.
The provided text is a 510(k) Premarket Notification for a medical device (Dimension® CSAE Cyclosporine Extended Range Calibrator). This type of document is administrative and regulatory, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC studies is not contained within the provided document. The document describes the device, its intended use, and claims equivalence to a previously cleared calibrator, but it does not detail a study proving specific performance metrics against pre-defined acceptance criteria.
To directly address your request given the provided text:
1. A table of acceptance criteria and the reported device performance
- Information not provided in the document. The document does not define specific performance acceptance criteria (e.g., accuracy, precision targets) for the calibrator, nor does it report performance metrics against such criteria. It states that the device is "substantially equivalent" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided in the document. There is no mention of a test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information not provided in the document. The concept of "ground truth" as it applies to an image analysis or diagnostic AI device (along with experts to establish it) is not relevant to a calibrator for a clinical chemistry assay, and therefore, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided in the document. Adjudication methods are not applicable to the assessment of a calibrator's performance described in this type of regulatory submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Information not provided in the document. MRMC studies are not applicable to a calibrator. This type of study is relevant for diagnostic imaging AI tools that assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not provided in the document. This question is not applicable to a calibrator. The calibrator itself is a reagent used in an automated clinical chemistry system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided in the document. "Ground truth" in the context of calibrators typically refers to the accurately assigned values of the analytes (cyclosporine in this case) within the calibrator vials. The document states the "target concentrations" are approximately 0, 200, 400, 800, 1400, and 2000 ng/mL, but it does not describe how these precise ground truth values were established methodologically for validation purposes.
8. The sample size for the training set
- Information not provided in the document. The concept of a "training set" is not applicable to a chemical calibrator.
9. How the ground truth for the training set was established
- Information not provided in the document. Not applicable.
In summary, this 510(k) submission focuses on regulatory equivalence for a chemical calibrator and does not contain the detailed clinical study performance data or methodology typically found for diagnostic AI devices, which your questions are geared towards.
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FEB 1 6 2006
Dade Behring Inc. Dade Behring Inc.
510(k) Premarket Notification – Dimension® CSAE Cyclosporine Extended Range Calibrator
510(k) Summary Emit® 2000 Cyclosporine Specific Assay
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation
Manufacturer:
P.O. Box 6101. Newark, DE 19714-6101
Dade Behring Inc.
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
Oct. 27, 2005
Device Name / Classification 2.
Dimension® CSAE Cyclosporine Extended Range Calibrator / Class II
Identification of the Predicate Device 3.
Dimension® CSAE Cyclosporine Extended Range Calibrator, K052015
4. Device Description
The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of one vial of each calibrator level 0-5. The target concentrations of the calibrator levels are approximately 0, 200, 400, 800, 1400 and 2000 ng/mL of cyclosporine.
Level 0 is used for dilution of over-range samples (>2000 ng/mL) in order to obtain Lover o lood for analyange; it is not used in calibration. Levels 1 through 5 are used for calibration of the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.
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Device Intended Use 5.
The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro I he Dimension® CSAL Cyclosportio Extended to calibrate the Cyclosporine A, Extended Range diagnostic product intended to be used to canerals are stry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.
Medical device to which equivalence is claimed and comparison information 6.
The Dimension® CSAE Cyclosporine Extended Range Calibrator is equivalent to the The Dimension® Corner Corporation Color K052015. The intended use of this product has been candrator previously of the calibrator with the Emit® 2000 Cyclosporine Specific mouried to menade as of the canolas formulation or operating principle to allow its use With the Emit® 2000 Cyclosporine Specific Assay. The Dimension® CSAE with the Extended Range Calibrator with the modified intended use is substantially equivalent to the cleared Dimension® CSAE Cyclosporine Extended Range Calibrator (K052015).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined lines forming a stylized representation of a staff with a serpent coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
FEB 1 6 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yuk-Ting Lewis Regulatory Affairs & Compliance Manager Dade Behring Inc. PO Box 6101, M/S 514 Newark DE 19714-6101
K053108 Re:
R053100
Trade/Device Name: Dimension® CSAE Cyclosporine Extended Range Calibrator Regulation Number: 21 CFR§862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: February 8, 2006 Received: February 9, 2006
Dear Ms. Lewis:
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 for association in the 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) I mis icter will and w you to begal finding of substantial equivalence of your device to a legally premarket notification: "The 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 yourstions on the promotion and advertising of your device, please contact the Office of In of quostions on the promie 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 I va may 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 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
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Dade Behring Inc. Dade Behring Inc.
510(k) Premarket Notification -- Dimension® CSAE Cyclosporine Extended Range Calibrator
Indications for Use
510(k) Number (if known):
Dimension® CSAE Cyclosporine Extended Range Calibrator Device Name:
KOS3108
Indications For Use:
The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the The CSAE Calibrator is an in Vitro diagliosus procession® clinical chemistry system Cyclosporine Fr, it® 2000 Cyclosporine Specific Assay.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ann Chappie
Page 1 of 1
Affice of In Vitro Diagnostic Device Evaluation and Safety
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.