(4 days)
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.
The cobas Elecsys® Prolactin II CalSet consists of a lyophilized buffered equine serum matrix with added recombinant prolactin in two concentration ranges. The CalSet can be used with all reagent lots.
The provided text is for a 510(k) summary for a "cobas Elecsys® Prolactin II CalSet" and does not contain the detailed study information typically requested for AI/ML-based medical devices. The device is a calibrator for an immunoassay system, not an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable.
However, based on the context of a 510(k) submission for a calibrator, we can infer some information relevant to "acceptance criteria" and "proof of meeting criteria" in this specific context.
Here's an attempt to answer based solely on the provided document, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
For a calibrator, the "acceptance criteria" and "performance" are primarily related to its equivalence to a predicate device and its ability to consistently calibrate the associated assay. The document highlights similarities and differences with the predicate.
| Criterion Type | Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance (cobas Elecsys® Prolactin II CalSet) |
|---|---|---|
| Intended Use | Calibrate quantitative Elecsys Prolactin (or equivalent) assay on Elecsys immunoassay systems | Calibrates quantitative Elecsys Prolactin II assay on Elecsys immunoassay systems |
| Analyte Calibrated | Prolactin | Prolactin |
| Standardization | Standardized using 3rd IRP WHO Reference Standard 84/500 | Standardized using 3rd IRP WHO Reference Standard 84/500 |
| Calibrator Levels | Low: approx. 2 µIU/mL, High: approx. 2,000 µIU/mL | Low: approx. 2 µIU/mL, High: approx. 2,000 µIU/mL |
| Storage (Unopened) | Stable at 2-8°C up to expiration date | Stable at 2-8°C up to expiration date |
| Storage (Opened, Analyzer) | Stable at 2-8°C for 8 weeks (predicate) | At 20-25°C, use only once (modified device) |
| Storage (Opened, Freeze) | Not applicable (predicate was liquid) | At -20°C for 3 months (freeze only once) |
Study Proving Device Meets Acceptance Criteria:
The document describes a "Device Comparison" study as the primary means to demonstrate that the new device (cobas Elecsys® Prolactin II CalSet) is "substantially equivalent" to its predicate (Elecsys Prolactin CalSet, K964748). This comparison is presented in a table form, highlighting the similarities. The changes (matrix change to buffered equine serum, storage form to lyophilized, and updated opened storage conditions) are explicitly mentioned as "modifications." The FDA's letter states they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent." This determination is the proof that the device meets the acceptance criteria for a 510(k) pathway, which primarily involves demonstrating equivalence to a legally marketed predicate.
Missing Information (and why it's missing for this type of device):
The following information is not provided because the device is a calibrator, not an AI/ML diagnostic tool, and the submission is a 510(k) for substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator's 510(k) submission focused on equivalence. Performance studies for calibrators typically involve analytical studies (e.g., precision, accuracy using reference values), not patient-level test sets.
- 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): Not applicable. Ground truth for a calibrator's value is established through metrological traceability to international reference standards, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical calibrator kit, not a software algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, the "ground truth" for its assigned values (e.g., 2 µIU/mL) would be established by standardization against the "3rd IRP WHO Reference Standard 84/500," as stated in the document. This is a primary reference material, not clinical outcomes or expert consensus.
- The sample size for the training set: Not applicable. There is no machine learning model involved.
- How the ground truth for the training set was established: Not applicable.
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510(k) Summary - cobas Elecsys® Prolactin II CalSet
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3532Contact person: Randy JohnsonDate prepared: October 21, 2005 |
| Device Name | Proprietary name: Roche Diagnostics cobas Elecsys® Prolactin II CalSetCommon name: Prolactin II CalSetClassification name: Calibrator, Secondary |
| Devicedescription | The cobas Elecsys® Prolactin II CalSet consists of a lyophilized buffered equine serum matrix with added recombinant prolactin in two concentration ranges. The CalSet can be used with all reagent lots. |
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510(k) Summary - cobas Elecsys® Prolactin II CalSet, continued
| Intended use | Elecsys Prolactin II CalSet is used for calibrating the quantitative ElecsysProlactin II assay on the Elecsys immunoassay systems. |
|---|---|
| PredicateDevice | The cobas Elecsys® Prolactin II CalSet is equivalent to other devices legallymarketed in the United States. We claim equivalence to the Elecsys ProlactinCalSet (K964748). |
| DeviceComparison | The table below illustrates the similarities between the Elecsys Prolactin(K964748) and the cobas Elecsys Prolactin II CalSet (modified device). |
| Topic | Elecsys® Prolactin(K964748) | cobas Elecsys® Prolactin II CalSet(Modified Device) |
|---|---|---|
| Intended use | Elecsys Prolactin CalSet is used forcalibrating the quantitative ElecsysProlactin assay on the Elecsysimmunoassay systems. | Elecsys Prolactin II CalSet is used forcalibrating the quantitative ElecsysProlactin II assay on the Elecsysimmunoassay systems. |
| Matrix | Buffer/protein | Buffered equine serum |
| Storage form | Liquid | Lyophilized |
| Levels | Low: approx. 2 µIU/mLHigh: approx. 2,000 µIU/mL | Same |
| Standardization | Standardized using the 3rd IRP WHOReference Standard 84/500 | Same |
| Stability | Unopened:at 2-8°C up to the expiration date. | Unopened:at 2-8°C up to the expiration date. |
| Opened:at 2 - 8°C; 8 weekson the analyzers, up to 5 hours in total | Opened:at -20°C; 3 months (freeze only once)on the analyzers at 20 - 25°C; use onlyonce |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2005
Randy Johnson MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250
Re: K052982
Trade/Device Name: cobas Elecsys Prolactin II CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: October 21, 2005 Received: October 24, 2005
Dear Mr. Johnson:
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 (sec 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 Gutierrez
Alberto Guticarez, 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):
Device Name: cobas Elecsys Prolactin II CalSet
Indications For Use:
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Harry Phillips
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Confidential
510(k) KD52982
20
§ 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.