← Product Code [DCK](/productcode/DCK) · K981871 # C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (K981871) _Diagnostic Systems Laboratories, Inc. · DCK · Nov 9, 1998 · Immunology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K981871 ## Device Facts - **Applicant:** Diagnostic Systems Laboratories, Inc. - **Product Code:** [DCK](/productcode/DCK.md) - **Decision Date:** Nov 9, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5270 - **Device Class:** Class 2 - **Review Panel:** Immunology ## 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. ## Device Story DSL 10-42100 CRP ELISA is an in vitro diagnostic kit for quantitative measurement of CRP in human serum. Principle of operation is a capture ELISA (sandwich assay); rabbit anti-human CRP antibody is immobilized on microtiter plate wells; patient serum CRP is captured and then bound by a second anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase. The assay is performed in a clinical laboratory setting. Healthcare providers use the resulting quantitative CRP levels to evaluate the extent of tissue injury in patients. The device provides objective data to assist in clinical assessment of inflammatory or injury states. ## Clinical Evidence Clinical comparison study performed with 79 patient samples (male and female) covering low, medium, and high serum CRP levels. Samples were assayed simultaneously using the subject device and the predicate device. Results demonstrated a correlation coefficient of r=0.98 and a linear regression equation of Y=0.827x + 349.44. ## Technological Characteristics Enzyme-Linked Immunosorbent Assay (ELISA) kit. Capture assay format using rabbit anti-human polyclonal antibodies. Detection via horseradish peroxidase enzyme conjugate. Quantitative measurement of CRP in human serum. ## Regulatory 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. ## Predicate Devices - Hemagen Diagnostics, Inc. CRP 150 Kit ([K944288](/device/K944288.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 K981871 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 _____________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda-staging.innolitics.com/device/K981871](https://fda-staging.innolitics.com/device/K981871) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com