(28 days)
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.
The Elecsys Prolactin II CalCheck calibration verification solutions comprise three levels - low, mid and high - each with a defined Prolactin concentration range. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle and the high solution is near the upper limit of the measuring range. Roche Diagnostics has validated that these materials are matrix compatible for use on the Elecsys systems.
The provided text describes the Elecsys Prolactin II CalCheck, a calibration verification material, and its equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it focuses on the regulatory submission and comparison to a legally marketed predicate device for the purpose of demonstrating substantial equivalence.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not available in the provided document.
Here's an attempt to extract relevant information wherever possible, and explicitly state when the requested information is not present:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement. The comparison provided is primarily focused on the characteristics and intended use of the new device relative to its predicate.
| Feature / Criterion | Predicate Device (Elecsys Prolactin CalCheck K970147) | Modified Device (Elecsys Prolactin II CalCheck) |
|---|---|---|
| Intended Use | Verification of calibration established by Elecsys Prolactin reagent on Elecsys® 2010 Immunoassay analyzers. | Verification of calibration established by Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers. |
| Matrix | Human serum | Buffered equine serum |
| Storage form | Lyophilized | Same (Lyophilized) |
| Target values | Low = 500 µIU/mL, Mid = 5,000 µIU/mL, High = 8,000 µIU/mL | Same (Low = 500 µIU/mL, Mid = 5,000 µIU/mL, High = 8,000 µIU/mL) |
| Traceability | Calibrated against the WHO Standard 84/500 | Same (Calibrated against the WHO Standard 84/500) |
| Stability (Unopened) | Up to the printed expiration date on the bottle labels at 2 - 8°C | Same (Up to the printed expiration date on the bottle labels at 2 - 8°C) |
| Stability (Reconstituted) | 4 hours at 15 - 25°C | Same (4 hours at 15 - 25°C) |
| Device Performance (e.g., accuracy, precision, etc.) | Not explicitly reported as acceptance criteria with numerical performance data in this document. The document primarily establishes substantial equivalence based on the characteristics listed above and intended use. | Not explicitly reported as acceptance criteria with numerical performance data in this document. The document primarily establishes substantial equivalence based on the characteristics listed above and intended use. |
The study described is a comparison study demonstrating substantial equivalence to a legally marketed predicate device (Elecsys Prolactin CalCheck K970147), rather than an explicit "acceptance criteria study" with specific performance thresholds for diagnostic accuracy. The key finding is the determination of substantial equivalence by the FDA.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on device characteristics and intended use, not clinical trial data with test sets.
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)
This information is not applicable/provided. The device is a "Calibration Verification Material," not a diagnostic device that requires expert interpretation for ground truth establishment in a clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided. (See #3 explanation).
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
This information is not applicable/provided. The device is a calibration verification material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a calibration verification material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibration verification material, the "ground truth" would likely be the assigned target values (Low, Mid, High concentrations) traceable to a recognized standard (WHO Standard 84/500), confirmed through analytical methods. This is not "expert consensus" in a clinical sense.
8. The sample size for the training set
This information is not applicable/provided. The device is a calibration verification material, and the provided document does not describe a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. (See #8 explanation).
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510(k) Summary - Elecsys Prolactin II CalCheck
| 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 |
|---|---|
| Submitter name, address, contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3532 |
| Contact person: Randy JohnsonDate prepared: October 28, 2005 | |
| Device name | Proprietary name: Roche Diagnostics Elecsys Prolactin II CalCheck |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) Analyte Controls (Assayed and Unassayed) | |
| Device description | The Elecsys Prolactin II CalCheck calibration verification solutions comprise three levels - low, mid and high - each with a defined Prolactin concentration range. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle and the high solution is near the upper limit of the measuring range. Roche Diagnostics has validated that these materials are matrix compatible for use on the Elecsys systems. |
Continued on next page·
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510(k) Summary - Elecsys Prolactin II CalCheck, Continued
| Intended use | For use in the verification of the calibration established by the ElecsysProlactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICSE170 Immunoassay analyzers. |
|---|---|
| Predicatedevice | The Elecsys Prolactin II CalCheck is equivalent to other devices legallymarketed in the United States. We claim equivalence to the Elecsys ProlactinCalCheck (K970147). |
| Devicecomparison | The table below illustrates the similarities between the Elecsys ProlactinCalCheck (K970147) and the Elecsys Prolactin II CalCheck (modifieddevice). |
| Topic | Elecsys Prolactin CalCheck(K970147) | Elecsys Prolactin II CalCheck(Modified Device) |
|---|---|---|
| Intended use | For use in the verification of thecalibration established by the ElecsysProlactin reagent on Elecsys® 2010Immunoassay analyzers. | For use in the verification of thecalibration established by the ElecsysProlactin II reagent on Elecsys1010/2010 and MODULARANALYTICS E170 Immunoassayanalyzers. |
| Matrix | Human serum | Buffered equine serum |
| Storage form | Lyophilized | Same |
| Target values | Low = 500 µIU/mLMid = 5,000 µIU/mLHigh = 8,000 µIU/mL | Same |
| Traceability | Calibrated against the WHO Standard84/500 | Same |
| Stability | Unopened:Up to the printed expiration date onthe bottle labels at 2 - 8°CReconstituted:4 hours at 15 - 25°C | Unopened:Up to the printed expiration date onthe bottle labels at 2 - 8°CReconstituted:4 hours at 15 - 25°C |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
NOV 2 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Randy Johnson, MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
K053059 Re:
Trade/Device Name: Elecsys Prolactin II CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 28, 2005 Received: October 31, 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 (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, 11 you atons 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 vours,
Alberto Gutierrez, Ph.D.
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): K053059
Device Name: Elecsys Prolactin II CalCheck
Indications For Use:
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD53059
Confidential
20
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.