(33 days)
The Elecsys® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.
The Elecsys® Parathyroid Hormone CalCheck is a lyophilized product manufactured using a human serum base, synthetic PTH, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
This document is a 510(k) summary for the Elecsys® Parathyroid Hormone CalCheck, a calibration verification material. It does not describe an AI/ML device or a study involving human readers or complex algorithms. The information provided is for a diagnostic product used to verify the calibration of an immunoassay. Therefore, it does not fit the criteria requested in the prompt regarding AI performance, human reader improvement, or complex ground truth establishment.
Here's an analysis based on the actual content of the document:
The document describes a diagnostic product (calibration verification material) and its regulatory clearance process, not a device that would require AI/ML performance metrics as outlined in the prompt. Therefore, many of the requested categories are not applicable.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Verification: Used to verify calibration of the Elecsys® Parathyroid Hormone assay. | Performance Characteristics: "The Elecsys® Parathyroid Hormone CalCheck was evaluated for value assignment and stability." (Specific quantitative data is not provided in this summary, but the device received 510(k) clearance, implying successful validation against its intended use.) |
| Levels: Three levels (low, mid, high) with defined PTH concentrations, positioned within the assay's measuring range (near lower detection limit, middle/clinically critical point, and near upper limit). | The product is designed with these three levels according to the description. |
| Material Composition: Lyophilized product using human serum base, synthetic PTH, and preservative. Analyte appropriately spiked. | The device description states this composition. |
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 510(k) summary. Given the nature of a calibration verification material, the "test set" would refer to internal validation data for value assignment and stability, which is not detailed here.
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 is not applicable to this type of device. The "ground truth" for a calibration verification material is its assigned value and stability, determined through laboratory methods, not expert consensus interpreting complex data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to this type of device. Adjudication methods are typically for subjective assessments or complex diagnostic interpretations, not for instrument calibration materials.
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 is not applicable to this type of device. This document describes a calibration material, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this type of device. The device is a physical reagent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device (calibration material) would be the analytically determined and assigned concentration values for parathyroid hormone (PTH) within the material, established through rigorous laboratory methods, likely using a reference method or highly characterized assay. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable to this type of device. There is no "training set" as this is not an AI/ML or statistical modeling device.
9. How the ground truth for the training set was established
This is not applicable to this type of device. As there is no training set, there is no ground truth to establish for it in this context.
Summary of what the document does provide:
- Device Name: Elecsys® Parathyroid Hormone CalCheck
- Intended Use: To verify the calibration of the Elecsys® Parathyroid Hormone assay.
- Device Description: Lyophilized product with human serum base, synthetic PTH, and preservative, spiked to correct CalCheck concentration levels.
- Performance Characteristics Evaluated: Value assignment and stability.
- Predicate Device: Elecsys® CalCheck™ TSH.
- Regulatory Clearance: 510(k) cleared (K993642) as substantially equivalent to the predicate.
{0}------------------------------------------------
.
:
| 510(k) Summary | NOV 30 1999 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 576 - 3723 |
| Contact Person: Priscilla A. Hamill | |
| Date Prepared: October 26, 1999 | |
| Device Name | Proprietary name: Elecsys® Parathyroid Hormone CalCheck |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed +unassayed) | |
| Predicatedevice | The Elecsys® Parathyroid Hormone CalCheck is substantially equivalent tothe currently marketed Elecsys CalCheck TSH. |
| Device ®Description | The Elecsys® Parathyroid Hormone CalCheck is a lyophilized productmanufactured using a human serum base, synthetic PTH, and preservative.The analyte is appropriately spiked into the CalCheck matrix to the correctCalCheck concentration levels. |
| Intended use | The Elecsys® Parathyroid Hormone CalCheck is used to verify the calibration of the Elecsys® Parathyroid Hormone assay. |
| Comparison to predicate device | The Elecsys® Parathyroid Hormone CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH.Both products are intended to be used for the verification of calibration for analytes on the Elecsys® Immunoassay Analyzers. |
| Performance Characteristics | The Elecsys® Parathyroid Hormone CalCheck was evaluated for value assignment and stability. |
NOV 300 1999
:
{1}------------------------------------------------
510(k) Summary, Continued
{2}------------------------------------------------
Image /page/2/Picture/1 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, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is simple, using a black and white color scheme.
NOV 300 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
K993642 Re:
Trade Name: Elecsys® Parathyroid Hormone CalCheck Regulatory Class: I Product Code: JJX Dated: October 26, 1999 Received: October 28, 1999
Dear Ms. Hamill:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Elecsys® Parathyroid Hormone CalCheck
Indications For Use:
Elecsys® Parathyroid Hormone CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined parathyroid hormone concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Peter E. Madeni
(Division Sign-Off)
Division of Clinical Laboratory Devices K993642
510(k) Number
.
§ 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.