The Wampole HS-CRP ELISA is an in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitative measurement of C-reactive protein (CRP) levels in human serum and plasma. CRP measurements aid in the evaluation of the extent of injury to body tissues.

Device Description

The Wampole™ HS-CRP ELISA is a Class II in vitro medical diagnostic device that utilizes conventional enzyme-linked immunosorbent assay technology to quantitatively measure the level of C-reactive protein (CRP) in a serum or plasma specimen. The assay kit consists of plastic microwell strips, containing adsorbed monoclonal anti-CRP antibody. CRP in the specimen is captured by the immobilized antibody, forming immobilized immune complexes. After washing away excess specimen, polyclonal anti-CRP antibody that has been conjugated to horseradish peroxidase is added, forming a "sandwich" of monoclonal antibody, CRP antigen, and conjugated polyclonal antibody. After washing, the immobilized CRP sandwich is exposed to tetremethlybenzidine (TMB), a chromogenic substrate that turns from clear to blue in the presence of peroxidase reaction products. The peroxidase reaction is stopped by the addition of dilute sulfuric acid, which also changes the color of the solution from blue to yellow. The optical density of the yellow end product is directly proportional to the amount of bound CRP antigen, and is quantitated on an ELISA reader at 450 nm. Specimen CRP levels are then determined by interpolation from a standard curve of optical density versus CRP concentration.

AI/ML Overview

The provided text does not contain explicit acceptance criteria tables or a detailed study description with all the requested information for the Wampole HS-CRP ELISA device. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance study report with specific acceptance criteria that the device must meet in a formal table with reported performance.

However, based on the information provided, I can infer some aspects and highlight what is missing.

Here's an attempt to answer your request given the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance in the typical format you requested (e.g., analytical precision, accuracy, limit of detection, etc., against specific numerical targets). The document states the device has "the same technological features, characteristics and intended use as the predicate device," implying that its performance is expected to be comparable to or meet the standards established for the predicate.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly stated in the provided text. The document mentions "human serum and plasma" specimens, but not the number of samples used in any specific test set or their origin (country, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not explicitly stated in the provided text. For an in vitro diagnostic (IVD) like an ELISA, ground truth is typically established by reference methods or clinical diagnosis rather than expert consensus on images.

4. Adjudication Method for the Test Set

This information is not applicable or explicitly stated in the provided text, as the device is an ELISA for measuring CRP levels, not a diagnostic imaging device requiring expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. This device is an in vitro diagnostic assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Wampole HS-CRP ELISA is a standalone in vitro diagnostic assay. Its performance is evaluated biochemically and quantitatively, not as an algorithm assisting a human interpreter. Therefore, its performance is inherently "standalone" in the context of laboratory testing. The document focuses on the assay's ability to quantitatively measure CRP.

7. The Type of Ground Truth Used

For an ELISA like the Wampole HS-CRP ELISA, the "ground truth" would typically be established by:

Reference materials/calibrators: Known concentrations of CRP used to generate standard curves.
Comparison to established reference methods: Testing patient samples and comparing results to a gold standard CRP measurement method or a highly accurate predicate device.
Clinical outcomes/diagnosis: While not directly mentioned for establishing the "ground truth" for the assay's analytical performance, CRP levels themselves aid in the "evaluation of the extent of injury to body tissues," which relates to clinical outcomes.

The document states "Specimen CRP levels are then determined by interpolation from a standard curve of optical density versus CRP concentration," indicating the use of reference materials/calibrators as part of establishing the measurement ground truth. The comparison to the predicate device (Dade Behring N High Sensitivity CRP - K991385) implies that the performance of the Wampole ELISA was benchmarked against an existing, legally marketed device that serves as a standard for CRP measurement.

8. The Sample Size for the Training Set

This information is not explicitly stated in the provided text. For ELISA assays, a "training set" in the context of machine learning isn't directly applicable. Instead, the assay is developed and optimized using a variety of samples and conditions to establish its analytical characteristics (e.g., linearity, precision, accuracy). The document does not specify the number of samples used during this development and validation phase.

9. How the Ground Truth for the Training Set Was Established

This information is not explicitly stated in the provided text, and the concept of a "training set" with ground truth as defined for AI/ML models is not directly applicable to a traditional ELISA. The development and optimization of an ELISA involve using known concentrations of purified analyte (CRP standards) and well-characterized human serum and plasma samples to ensure the assay performs as expected across its analytical range. These known concentrations and characterized samples serve as the basis for establishing the assay's analytical performance.

Summary

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Wampole HS-CRP ELISA 510(k) Notification II. 510(k) SUMMARY

June 11, 2001 Page 2 of 28

Submitted By:	Wampole LaboratoriesP.O. Box 1001Half Acre RoadCranbury, NJ 08512
Contact Person	Maureen GarnerManager, Regulatory AffairsCarter WallacePhone: (609) 655-6345
Date Prepared:	June 11, 2001
Proprietary Name:	Wampole™ HS-CRP ELISA
Common Name:	C-reactive protein test
Predicate Device:	Dade Behring N High Sensitivity CRP.510(k) Document Control Number: K991385

JAN 8 2002 K011855### Description of Device:

The assay kit consists of plastic microwell strips, containing adsorbed monoclonal anti-CRP antibody. CRP in the specimen is captured by the immobilized antibody, forming immobilized immune complexes. After washing away excess specimen, polyclonal anti-CRP antibody that has been conjugated to horseradish peroxidase is added, forming a "sandwich" of monoclonal antibody, CRP antigen, and conjugated polyclonal antibody. After washing, the immobilized CRP sandwich is exposed to tetremethlybenzidine (TMB), a chromogenic substrate that turns from clear to blue in the presence of peroxidase reaction products. The peroxidase reaction is stopped by the addition of dilute sulfuric acid, which also changes the color of the solution from blue to yellow. The optical density of the yellow end product is directly proportional to the amount of bound CRP antigen, and is quantitated on an ELISA reader at 450 nm. Specimen CRP levels are then determined by interpolation from a standard curve of optical density versus CRP concentration.

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II. 510(k) SUMMARY (cont'd)

Intended Use of the Device:

Technological Characteristics:

The Wampole HS-CRP ELISA uses conventional "microwell" technology, is similar in technology to other "sandwich" ELISA devices and it has the same characteristics and intended use as the predicate device. Other devices include those that detect circulating levels of lipoproteins or human chorionic gonadotropin (hCG). The Wampole HS-CRP ELISA has the same technological features, characteristics and intended use as the predicate device. The monoclonal and polyclonal antibodies used, as well as the recombinant standard antigen, all are derived from established technology. The colored end product is read on standard ELISA readers, which use monochromatic filters of wavelengths pre-selected for specific substrates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three wavy lines representing snakes or streams.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 2002 JAN

Ms. Maureen N. Garner Director, Regulatory Affairs Carter-Wallace, Inc. Wampole Laboratories Division P.O. Box 1001 Half Acre Road Cranbury, NJ 08512

Re: K011855

Trade/Device Name: Wampole HS-CRP ELISA Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: October 30, 2001 Received: October 31, 2001

Dear Ms. Garner:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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INDICATIONS FOR USE STATEMENT VI.

510(k) Number: KO11855

Wampole HS-CRP ELISA Device Name:

The Wampole HS-CRP ELISA is an in vitro diagnostic enzyme-Indications for Use: linked immunosorbent assay intended for the quantitative measurement of C-reactive protein (CRP) levels in human serum and plasma. CRP measurements aid in the evaluation of the extent of injury to body tissues.

さしみれ!
(Division Sign-Off)
✔Division Of Clinical Laboratory Devices
10(k) Nurnber K011555

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

-OR- Over-The-Counter Use ____________________________________________________________________________________________________________________________________________________ Precription Use

Regulation Number and Section

§ 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).