(165 days)
The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
The DSL C-Reactive Protein (CRP) ELISA kit was developed for the quantitative measurement of CRP in human serum. The ELISA format is a capture assay. Rabbit anti-human polyclonal antibody against CRP is immobilized to the inner surface of the microtiter plate wells. CRP in the standards or serum samples is "sandwiched" between this antibody and the anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase enzyme.
The provided text describes a 510(k) submission for the DSL 10-42100 C-Reactive Protein ELISA kit, which aims to demonstrate substantial equivalence to a legally marketed predicate device. While it details the device, its intended use, and a comparative study, it does not explicitly state specific acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the study's aim was to establish "substantial equivalence" based on a correlation coefficient.
Based on the provided information, here's what can be extracted and inferred regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (r) | Not explicitly stated as a numerical threshold, but implicitly, a strong correlation indicating substantial equivalence. | r = 0.98 |
| Linear Regression Equation | Not explicitly stated as a numerical threshold, but implicitly, a regression equation close to Y=X suggests close agreement. | Y = 0.827x + 349.44 |
Note: The FDA's determination of "substantial equivalence" is the overarching acceptance criterion addressed by the study. The study's results (high correlation coefficient) were deemed sufficient by the FDA for this determination.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
n = 79patient samples. - Data Provenance:
- Country of Origin: Not explicitly stated, but given the submitter's address (Webster, Texas, USA) and the FDA's regulatory context, it's highly probable the samples were collected in the USA.
- Retrospective or Prospective: Not explicitly stated. The phrasing "patient samples (n=79) were collected and assayed simultaneously by both methods" suggests a prospective collection for the purpose of this comparison, but it could also be a mix of newly collected and existing archived samples. Without more detail, it's difficult to definitively categorize. The samples were chosen "from male and female subjects with low, medium and high serum CRP levels," implying a controlled selection rather than purely retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study compares the new device (DSL CRP ELISA) against a predicate device (Hemagen Diagnostics, Inc. CRP 150 Kit), not against a human expert's interpretation or a "ground truth" established by experts in the typical sense of diagnostic imaging or clinical assessment. The ground truth, in this context, is effectively the measurement obtained by the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are usually relevant when multiple human reviewers independently assess data and their discrepancies need to be resolved to establish a consensus ground truth. In this study, measurements are quantitative and compared directly between two devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance. The described study is a direct comparison of a new laboratory diagnostic device with a predicate laboratory diagnostic device, without human readers in the loop for interpretation in the specified context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The study directly compared the measurements of the new DSL CRP ELISA kit (the "algorithm/device") against the predicate Hemagen Diagnostics CRP 150 Kit, without human interpretation as part of the primary output. The DSL 10-42100 C-Reactive Protein ELISA Kit is the standalone device.
7. The Type of Ground Truth Used
The "ground truth" for this study was effectively the measurements obtained from the legally marketed predicate device, the Hemagen Diagnostics, Inc. CRP 150 Kit. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate device's performance is assumed to be acceptable.
8. The Sample Size for the Training Set
This information is not provided in the document. The provided text describes a 510(k) submission, which focuses on validation, not the development or training of the device. ELISA kits are typically based on well-established biochemical principles and do not involve "training sets" in the same way machine learning algorithms do.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As mentioned above, ELISA kits do not typically have a "training set" in the machine learning sense. The assay's design and parameters would have been established through a standard biochemical development process, relying on known chemical reactions and established methodologies for measuring CRP.
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9 1998
Dice ostic Systems Laboratories, I
445 Medical Center Boulev
Webster Texas 77598-4217 U
Tel 281.332.95
Fcx 281.554.42
Email mita@delabs a
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-42100 C-Reactive Protein ELISA Name of Device: Enzyme-Linked Immunosorbent Assay Classification Name: Analyze Code and Name: C-Reactive Protein Requlatory Class: 11
John Class Submitter: Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678
Date: Mav 28, 1998
The DSL C-Reactive Protein (CRP) ELISA kit was developed for the quantitative measurement of CRP in human serum. The ELISA format is a capture assay. Rabbit anti-human polyclonal antibody against CRP is immobilized to the inner surface of the microtiter plate wells. CRP in the standards or serum samples is "sandwiched" between this antibody and the anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase enzyme.
The DSL CRP ELISA assay is intended for the quantitative determination of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
The DSL CRP ELISA is substantially equivalent to the Hemagen Diagnostics, Inc. 34-40 Bear Hill Road, Waltham, MA 02154, CRP 150 Kit 510(k) No. K944288. These kits have the same intended use.
To demonstrate substantial equivalence between the two assays, patient samples (n=79) were collected and assayed simultaneously by both methods. Samples were chosen from male and female subjects with low, medium and high serum CRP levels. Linear regression analysis of the results obtained for the comparison with the CRP assay gave the equation Y=0.827x + 349.44 with a correlation coefficient of (r) = 0.98.
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Image /page/1/Picture/2 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of three faces in profile, overlapping each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
9 1998 NOV
John Class DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 Medical Center Boulevard Webster, TX 77598
Re: K981871 Trade Name: DSL 10-42100 C-Reactive Protein ELISA Regulatory Class: II Product Code: DCK Dated: August 20, 1998 Received: August 21, 1998
Dear Mr. Class:
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 Requlations, 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 QS 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. this response to your premarket notification Please note: 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 requlations.
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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 leqally 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 qeneral 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
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
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FDA 1000HV00E/0110
21 Non SJ 206 5 3
长981871 501(k) Number (if known):
Device Name: C-Reactive Protein ELISA, DSL-10-42100
Indications for use:
The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
(PLESE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
Rita E. Madson
Prescritition Use
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).