(64 days)
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.
Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.
The provided document is a 510(k) clearance letter for the Randox Calibration Serum, a Class II medical device. It does not contain information regarding detailed acceptance criteria, device performance studies, or the methodologies typically associated with assessing the clinical accuracy or effectiveness of diagnostic devices in the way requested in the prompt.
The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It lists the analytes the calibration serum is intended to measure and clarifies its use as an in vitro diagnostic product for calibration in clinical chemistry assays. It does not describe a study that proves the device meets specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or how it impacts human reader performance, as would be relevant for an AI-powered diagnostic device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
Here's a breakdown of why the requested information is not available in the provided text:
- Acceptance Criteria & Reported Performance: This document states the device is intended for use as a calibration serum and its concentrations and activities are suitable for calibration. It does not provide specific numerical acceptance criteria (e.g., within a certain percentage of a reference value) for its calibration accuracy, nor does it report specific performance metrics like bias, precision, or recovery rates that would typically be evaluated for a calibrator. The regulatory submission would have included analytical performance data, but that data is not part of this clearance letter.
- Sample Size (Test Set) & Data Provenance: Not applicable in the context of this document. Calibrators are tested for their stability, accuracy of assigned values, and matrix effects, not against a "test set" in the sense of patient samples for diagnostic performance.
- Number of Experts & Qualifications (Ground Truth): Not applicable for a calibration serum. The "ground truth" for a calibrator is typically established through reference methods and certified reference materials, not expert consensus on patient data.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study evaluates the impact of an AI algorithm on human diagnostic performance, which is not relevant for a calibration serum.
- Standalone (Algorithm Only) Performance: Not applicable. The device is a physical reagent (calibration serum), not an algorithm.
- Type of Ground Truth Used: The "ground truth" for a calibration serum's values would be based on validated reference methods and certified reference materials, ensuring traceability to primary standards. This is not explicitly detailed in the clearance letter.
- Sample Size for Training Set: Not applicable. This device is not an AI model that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, the provided text from the FDA 510(k) clearance letter for a calibration serum does not contain the information requested in the prompt because the prompt's questions are designed for evaluating diagnostic devices, particularly AI/machine learning-based ones, and not for a calibration standard.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 3 2006
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories, Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K053153
Trade/Device Name: Randox Calibration Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 28, 2005 Received: November 15, 2005
Dear Dr Armstrong;
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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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 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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Indications for Use
510(k) Number (if known): NOT KNOWN
CALIBRATION SERUM LEVELS 2 & 3 Device Name:
Indications For Use:
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 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 Benam
Page 1 of 2
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CALIBRATION SERUM LEVELS 2 & 3 - Catalogue Numbers CAL2350 & CAL2351
| Analyte | Analyte |
|---|---|
| Albumin | Gamma-GT |
| Aldolase | GLDH |
| Alkaline Phosphatase | Glucose |
| ALT (GPT) | α-HBDH |
| Amylase Pancreatic | Iron |
| Amylase Total | Lactate |
| Acid Phosphatase (non-prostatic) | LAP |
| Acid Phosphatase (Prostatic) | LD (LDH) |
| Acid Phosphatase (Total) | Lipase |
| AST (GOT) | Lithium |
| Bile Acids | Magnesium |
| Bicarbonate | Osmolality |
| Bilirubin Direct | Phosphate Inorganic |
| Bilirubin Total | Potassium |
| Calcium | Protein Total |
| Cholesterol | Sodium |
| Chloride | TIBC |
| Cholinesterase | Triglycerides |
| CK Total | Uric Acid (Urate) |
| Copper | Urea |
| Creatinine | Zinc |
| D-3-Hydroxybutyrate |
Page 2 of 2
Carol Benson
K053/53
§ 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.