← Product Code [LYR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR) · K022356 # NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY (K022356) _Nichols Institute Diagnostics · LYR · Oct 25, 2002 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR/K022356 ## Device Facts - **Applicant:** Nichols Institute Diagnostics - **Product Code:** [LYR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR.md) - **Decision Date:** Oct 25, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3110 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## Indications for Use The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is intended for use with the Nichols Advantage® Specialty System for the qualitative determination of anti-H. pylori IgG antibodies in human serum to aid in the diagnosis of infection by H. pylori. ## Device Story The Nichols Advantage® H. pylori IgG Antibodies Immunoassay is a two-site chemiluminescence immunoassay performed on the Nichols Advantage® Specialty System. The device uses human serum samples, which are incubated with a biotinylated H. pylori antigen cocktail and streptavidin-coated magnetic particles. After washing, acridinium-ester-labeled mouse monoclonal anti-human IgG antibodies are added to form a sandwich complex. The system automatically performs all incubation, separation, and washing steps. Trigger solutions (hydrogen peroxide and sodium hydroxide) are injected to oxidize the acridinium ester, causing light emission measured in relative light units (RLU) by an integrated luminometer. The light output is directly proportional to the anti-H. pylori IgG titer. The system calculates results based on a stored calibration curve and generates a report for the clinician. Used in clinical laboratory settings, the device aids healthcare providers in diagnosing H. pylori infection by quantifying antibody levels. ## Clinical Evidence Performance evaluated via method comparison against the predicate device. Study included 79.4% concordance, with 91.1% positive percent agreement (95% CI: 87%-95%) and 75.3% negative percent agreement (95% CI: 70%-81%). Precision studies showed intra-assay CVs of 4.7%-9.1% and inter-assay CVs of 15%-23%. Recovery ranged from 92%-118% and parallelism from 89%-117%. High dose hook effect was not observed below 1:20,000 titer. ## Technological Characteristics Two-site chemiluminescence immunoassay. Solid phase: streptavidin-coated magnetic particles. Label: acridinium ester. Detection: luminometer measuring RLU. Automated system handles sample/reagent addition, temperature-controlled incubation (37°C), and washing. Connectivity: integrated system. Software: automated calculation of results from stored calibration curve. ## Regulatory Identification Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans. ## Predicate Devices - Orion Diagnostica Pyloriset® EIA-G Immunoassay ([K971537](/device/K971537.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}------------------------------------------------ K022356 2.5 2002 Nichols Institute Diagnostics Nichols Advantage® H. pvlori IgG Antibodies 510(k) Notification # 11.0 510(k) SUMMARY This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 510(k) Number: not known ## 1. Name of Submitter, Contact Person and Date Summary Prepared: Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: 949-240-5260 Fax: 949-940-7313 Contact Person: James A. Rybski, Ph.D. Date Prepared: July 16, 2002 ## 2. Device Name: | Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Helicobacter
pylori IgG Antibodies Immunoassay | |-------------------------|----------------------------------------------------------------------------------------| | Common/Usual Name: | Anti-H. pylori IgG Assay | | Classification Name: | Campylobacter pylori Serological Reagents | #### 3. Predicate Device: We claim substantial equivalence to the Orion Diagnostica Pyloriset® EIA-G Immunoassay (K971537, Cleared June 27, 1997). # 4. Device Description: The Nichols Advantage® Helicobacter pylori IgG Antibodies Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System. # Chemiluminescence Nichols Institute Diagnostics utilizes chemiluminescence acridinium esters as the label in its specialty chemiluminescence system. Acridinium esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in diluted acid and Trigger 2 solution contains diluted sodium hydroxide. The system automatically injects Trigger solutions 1 and 2 into the {1}------------------------------------------------ wells of the cuvette which oxidize the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light, which is quantified in two seconds and is expressed in relative light units (RLU) by the integrated system luminometer. #### Immunometric Assay The Nichols Advantage® Anti-H. pylori IgG Assay is a two-site chemiluminescence immunoassay for the measurement of anti-H. pylori IgG in human serum. It utilizes an acridinium-ester-labeled mouse monoclonal anti-human IgG antibody and a biotinylated H. pylori antigen cocktail. The sample containing anti-H. pylori IgG antibodies is incubated with the biotinylated antigen cocktail and magnetic particles for 10 minutes at 37°C. Free, unbound biotinylated antigens and anti-H. pylori IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. Thereafter, acridinium-labeled anti-human IgG antibodies are added to the reaction mixture and a second 10 minute incubation follows creating the sandwich complex. Free, unbound acridinium-labeled anti-human IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. The wells containing the washed magnetic particles are transported into the system luminometer, which automatically injects Trigger 1 and Trigger 2, initiating the chemiluminescence reaction. The light is quantitated by the luminometer and expressed as RLU. The amount of bound-labeled antibody is directly proportional to the titer of anti-H. pylori IgG antibodies in the sample. #### Automation The Nichols Advantage Specialty System automatically handles sample dilution as well as sample and reagent additions, the temperature-controlled incubation, separation/washing step, and measurement of the light output. It calculates test results for controls and patient samples from the stored calibration curve, and generates a printed report, which includes patient information. # 5. Intended Use: The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is intended for use with the Nichols Advantage® Specialty System for the qualitative determination of anti-H. pylori IgG antibodies in human serum to aid in the diagnosis of infection by H. pylori. #### 6. Comparison to predicate device: The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is substantially equivalent to other products in commercial distribution {2}------------------------------------------------ for similar use. Most notably, it is substantially equivalent to the Orion Diagnostica Pyloriset® EIA-G Immunoassay. The following tables compare the Nichols Advantage Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay with the predicate device, Orion Diagnostica's Pyloriset EIA-G Immunoassay. ## Similarities: - Intended Use: For the qualitative determination of anti-H. pylori IgG antibodies in . human serum. - Both assays use an H. pylori antigen cocktail to bind human anti-H. pylori . antibodies. - Both assays use human serum for the test sample. . - Both assays rely upon a sandwich formation by antibodies specific to human IgG . to detect anti-H. pylori IgG antibodies. - The sensitivity of both assays is sufficient to measure anti-H. pylori IgG antibody . levels found in Helicobacter pylori-infected patients. | | Nichols Advantage®
Helicobacter pylori IgG
Antibodies Assay | Orion Diagnostica
Pyloriset® EIA-G
Immunoassay | |-------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | | | Sample Size | Five (5) microliters | 0.5 microliters*
*100 microliters of a 1:201
dilution of the sample | | Calibration | Two point calibration every two
weeks (maximum) of stored
working calibration curve; or
when controls out of range. | Four point standard curve run
with each assay. | | Solid Phase | Streptavidin-coated magnetic
particles. Streptavidin-biotin
separation technology. | Helicobacter pylori antigen
cocktail adsorbed to microtiter
plate wells. Antibody
sandwich-formation separation
technology. | | Incubation | Two Incubations:
Total of 20 minutes at 37°C | Three Incubations:
Total of 2 hr 30 min at room
temperature (20-25°C) | | Sensitivity | Less than or equal to 1:10 titer | Not described in the Directional
Insert | #### Differences: {3}------------------------------------------------ # Performance Characteristics: | FEATURE | Nichols Advantage®
Chemiluminescence
Anti- H. pylori IgG | | | Orion Diagnostica
Pyloriset® EIA-G Immunoassay | |--------------------------------|-----------------------------------------------------------------------|-------|-----|---------------------------------------------------| | | Mean
(titer) | SSD | %CV | | | Intra-Assay | 34 | 2.9 | 8.5 | None given | | | 241 | 11.3 | 4.7 | | | | 1471 | 133.9 | 9.1 | | | Inter-Assay | 26 | 6.0 | 23 | None given | | | 238 | 38.1 | 16 | | | | 2225 | 333.8 | 15 | | | Recovery | 92% - 118% | | | None given | | Parallelism | 89% - 117% | | | None given | | High Dose Hook Effect | Less Than 1:20,000 titer | | | None given | | Method Comparison | | | | | | Range of Results | 1:13 to 1:5526 | | | 1:97 to 1:9504 | | Concordance: | 79.4% | | | | | Percent Agreement Positive: | 91.1% (95%CI: 87% to 95%) | | | | | Percent Agreement
Negative: | 75.3% (95%CI: 70% to 81%) | | | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is written in a serif font. The text is centered on the image and is the only element present. Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # OCT 2 5 2002 James A. Rybski, Ph.D. Manager, R&D Scientific and Clinical Affairs Nichols Institute Diagnostics 1311 Calle Batido San Clemente, California 92673 Re: k022356 > Trade/Device Name: Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Assay Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: September 30, 2002 Received: October 18, 2002 Dear Dr. Rybski: 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 mav 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, {5}------------------------------------------------ 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 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" (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 {6}------------------------------------------------ Nichols Institute Diagnostics Nichols Advantage™ H. pylori IgG Antibodies 510(k) Notification #### INDICATIONS FOR USE STATEMENT 4.0 ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): _ KO323562 Device Name: Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay Indications For Use: The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is intended for use with the Nichols Advantage® Specialty System for the qualitative determination of anti-H. pylori IgG in human serum to aid in the diagnosis of infection by H. pylori. Freddie M. Poole (Division Sign-Off) Division of Clinical 510(k) Number - OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR/K022356](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR/K022356) **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. 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