(165 days)
Not Found
No
The description details a standard ELISA kit for measuring CRP, a well-established laboratory technique that does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic immunoassay kit used for quantitative measurement of CRP in human serum, which aids in evaluation, not treatment, of injuries to body tissues.
Yes
The device is a laboratory test kit designed for the quantitative measurement of C-Reactive Protein (CRP) in human serum, and this measurement "aids in the evaluation of the amount of injury to body tissues," which is a diagnostic purpose.
No
The device is a laboratory assay kit, which is a collection of physical reagents and materials, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit provides materials for the "quantitative measurement of CRP in human serum." This is a measurement performed in vitro (outside the body) on a biological sample (serum) to provide information about a patient's health status (evaluation of tissue injury).
- Device Description: The description details an "ELISA kit" which is a common type of laboratory test performed in vitro to detect and quantify substances in biological samples.
- Performance Studies: The performance studies describe testing "patient samples" using the device, which is characteristic of an IVD being evaluated for its ability to measure a substance in human biological material.
- Predicate Device: The mention of a "Predicate Device" with a K number (K944288) indicates that this device is being compared to a previously cleared medical device, which is a standard process for IVDs seeking regulatory clearance.
All these points strongly indicate that the DSL-10-42100 C-Reactive Protein (CRP) ELISA Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DSL 10-42100 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-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.
Product codes (comma separated list FDA assigned to the subject device)
DCK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows a stylized logo or monogram consisting of two lowercase letters, 'd' and 'u', interlocked or closely positioned. The letters are rendered in a bold, sans-serif font and appear to be solid black against a white background. The 'd' is on the left, and the 'u' is on the right, with the upper part of the 'd' connecting to the top of the 'u'.
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.
1
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.
2
Page 2
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
3
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 _____________________________________________________________________________________________________________________________________________________________