(67 days)
The ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Aq reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.
ChlamydiaTrol Ag is a liquid quality control reagent classified under Multi Analyte Controls(assayed and unassayed). ChlamydiaTrol Ag reagent is prepared from Chlamydia trachomatis elementary bodies extracted from infected mouse L cells grown in culture. Optimally infected cells are harvested and disrupted by sonication, and cellular debris is removed by centrifugation. Chlamydia trachomatis elementary bodies used in the preparation of ChlamydiaTrol Ag reagent have been rendered noninfectious by treatment with gamma radiation. The reagent contains human serum albumin(HSA), preservatives and stabilizers.
The provided text describes the acceptance criteria and study for ChlamydiaTrol™ Ag, a liquid unassayed quality control reagent for Chlamydia trachomatis antigen detection.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
As an unassayed quality control reagent, ChlamydiaTrol Ag does not have assigned reference values or traditional analytical acceptance criteria like sensitivity, specificity, or accuracy compared to a gold standard. Instead, its performance is assessed based on its reactivity, reproducibility, and stability within various commercial Chlamydia trachomatis diagnostic kits. The acceptance criteria essentially revolve around demonstrating consistent and predictable performance as a control.
| Acceptance Criteria Category | Specific Criteria/Measurement | Reported Device Performance | Study Reference |
|---|---|---|---|
| Reactivity | Produce a positive reaction within a target range established by each laboratory for each lot of reagent (no assigned values). | Demonstrated consistent reactivity (mean absorbance values, Sample to Cutoff ratios) across different commercial test kits, lots, and clinical sites. | Table 1 (representative levels), Tables 7-12 (clinical evaluation, specific results) |
| Within-run Precision | Coefficient of Variation (CV) | CVs ranging between 2.1% and 19.9% for within-run precision. | Table 2 (data not explicitly shown, but summarized in text) |
| Between-run Precision | Coefficient of Variation (CV) | CVs ranging between 2.1% and 19.9% for between-run precision. | Table 3 (data not explicitly shown, but summarized in text) |
| Elevated Temperature Stability | Performance consistent with reagent stored at 2-8°C after storage at room temperature (20-25°C) and 37°C. | Consistent performance observed. | Table 4 (data not explicitly shown, but summarized in text) |
| Freeze/Thaw Stability | Reactivity not affected by freezing (-20°C) and thawing. | Reactivity unaffected over multiple freeze/thaw cycles. | Table 5 (data not explicitly shown, but summarized in text) |
| Open Vial Stability | Consistent performance for up to 60 days after opening. | Consistent performance demonstrated for up to 90 days, substantiating the 60-day claim. | Table 6 (data not explicitly shown, but summarized in text) |
| Clinical Performance (Consistency among sites/methods) | Consistent performance in clinical laboratory settings, assuring safety and effectiveness under normal conditions of use. | Consistent mean values, S/CO ratios, and CVs observed across 8 clinical sites, 2 reagent lots, and 3 different commercial test methods. CVs for Abbott Chlamydiazyme EIA: 13.7% to 18.9%. CVs for Abbott LCx Chlamydia trachomatis Assay: 5.0% to 9.5%. | Tables 7-13 |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Evaluation Test Set:
- Sample Size: Not explicitly stated as a single "sample size" of specimens. Instead, the study involved:
- 2 different lots of ChlamydiaTrol Ag reagent.
- Evaluated by eight clinical investigators (sites).
- Using three different commercial test systems.
- Each "result(n) for ChlamydiaTrol Ag represents a single determination" (Page 5, Section 5.2). The total number of runs/determinations varied among sites and test kit lots.
- Data Provenance: Prospective, collected from June 1996 through May 1997 ("During the period from June, 1996 through May, 1997, two different lots of ChlamydiaTrol Ag reagent were evaluated by eight clinical investigators..." - Page 5, Section 5.0). The geographic origin of the clinical sites is not specified, but the submission is to the US FDA, implying US-based sites.
- Sample Size: Not explicitly stated as a single "sample size" of specimens. Instead, the study involved:
-
Reproducibility Test Set (Within-run/Between-run):
- Within-run: 20 replicates of the same sample.
- Between-run: Single test results of the sample in multiple test runs.
- Data Provenance: Not explicitly stated, likely internal Blackhawk BioSystems testing.
-
Stress Testing (Temperature, Freeze/Thaw, Open Vial):
- Sample Size: Not explicitly stated as number of replicates, but involved "two different lots of reagent" for temperature and open vial studies.
- Data Provenance: Not explicitly stated, likely internal Blackhawk BioSystems testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- N/A (Not Applicable): For this device, ground truth as typically defined (e.g., confirmed disease status) is not used. ChlamydiaTrol Ag is a quality control reagent, not a diagnostic device. Its "performance" is judged by its consistent and reproducible reactivity within various diagnostic assays, as monitored by the clinical laboratories themselves, rather than against a disease endpoint. The "ground truth" for its intended use is its ability to consistently produce a positive reaction within a laboratory's established range.
4. Adjudication Method (for the test set)
- N/A (Not Applicable): As a quality control reagent, there is no "ground truth" in the diagnostic sense to adjudicate against. The results reported by each site were analyzed to determine mean value, standard deviation, and coefficient of variation (Page 5, Section 5.1). Consistency across sites and methods serves as the metric of acceptable performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A (Not Applicable): This is not an AI-based diagnostic device and therefore an MRMC study comparing human readers with and without AI assistance is not relevant. The device is a liquid quality control reagent for Chlamydia trachomatis antigen tests.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (Not Applicable): This is not an algorithm or AI device. It's a laboratory reagent. Its "standalone" performance relates to its inherent stability and reactivity, as demonstrated in the reproducibility and stress testing, but not in the context of an algorithm.
7. The type of ground truth used
- For this quality control reagent, the "ground truth" is its inherent property to produce a consistent and measurable positive signal within various commercial Chlamydia trachomatis antigen detection assays. This is affirmed by:
- Batch consistency: Lots designed to produce a positive reaction within a target range.
- Analytical reproducibility: Low coefficients of variation in repeated testing.
- Stability over time and under stress conditions: Maintaining reactivity under various storage and handling conditions.
- Consistency across different test methods and clinical sites: Showing comparable results when used with different commercial kits by different laboratories.
8. The sample size for the training set
- N/A (Not Applicable): This device is a biochemical reagent, not a machine learning model. Therefore, there is no "training set" in the context of AI/algorithms. The reagent itself is manufactured and formulated using Chlamydia trachomatis elementary bodies and human proteins.
9. How the ground truth for the training set was established
- N/A (Not Applicable): As there is no training set for an AI/algorithm, this question is not relevant. The quality of the manufactured reagent (e.g., the concentration of Chlamydia trachomatis elementary bodies and the formulation with stabilizers) is established through manufacturing processes and internal quality control, not by establishing a ground truth for a training set.
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AUG 1 2 1997
PREMARKET NOTIFICATION FOR CHLAMYDIATROL™ AG
510(k) SUMMARY
Prepared June, 1997
For more information, please contact: Carole Polito
Blackhawk BioSystems, Inc. 12945 Alcosta Blvd. San Ramon, CA 94583 (510) 866-1458
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PREMARKET NOTIFICATION FOR CHLAMYDIATROL™ Ag
510(k) Summary
TABLE OF CONTENTS
INTRODUCTION 1.0
- Name and Intended Use 1.1
- Summary and Principles of the Procedure 1.2
- Substantial Equivalence 1.3
REAGENTS AND STORAGE 2.0
PERFORMANCE 3.0
- Expected Results 3.1
- Reproducibility 3.2
STRESS TESTING 4.0
- Elevated Temperature Studies 4.1
- Freeze/Thaw Studies 4.2
- Open Vial Stability 4.3
CLINICAL EVALUATION 5.0
- Materials and Methods રે 1
- 5.2 Results
- Discussion 5.3
- CONCLUSION 6.0
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1.0 INTRODUCTION
1.1 Name and Intended Use
ChlamydiaTrol™ Ag is a liquid unassayed quality control reagent intended for use with in vitro diagnostic assay procedures for the qualitative detection of Chlamydia trachomatis antigen. ChlamydiaTrol Ag reagents are designed for routine use to provide a means of estimating precision and monitoring performance of manual and automated test systems.
Summary and Principles of the Procedure 1.2
Monitoring the performance of laboratory test procedures through use of a well designed quality assurance program provides added confidence in the reliability of test results obtained for unknown specimens. Use of independent quality assurance reagents provides a means of monitoring performance of laboratory procedures on a routine basis and analyzing system performance on a retrospective basis. Routine monitoring of test performance will assist the laboratorian in identifying random or systematic errors and detecting trends, biases or other problems as they occur. A laboratory's analyses can be compared with those of other laboratories or with its own prior analyses by routinely analyzing test samples that have been obtained from a large common pool. Inclusion of ChlamydiaTrol Ag reagents in every test run will provide the laboratory with a means of estimating precision and reproducibility, and monitoring overall system performance on a run-to-run basis. Proper use of ChlamydiaTrol Ag reagents can assist laboratories in analyzing and identifying problems in a test run and improving the quality and proficiency of routine testing.
ChlamydiaTrol Ag reagents have been designed for use with in vitro diagnostic assay procedures for purposes of monitoring assay performance and maintaining quality assurance. ChlamydiaTrol Ag reagents are prepared using elementary bodies derived from Chlamydia trachomatis and contain human proteins and stabilizers. Source materials have been processed and treated to eliminate unwanted components and to inactivate infectious agents. The reagent has been formulated to ensure stability of the final product. Although ChlamydiaTrol Ag reagents do not have assigned values, each lot of material is designed to produce a positive reaction within a target range established by each laboratory for each lot of reagent. ChlamydiaTrol Ag reagents should be analyzed in the manner described for control specimens in accordance with instructions supplied by the manufacturer of the test kit being used.
1.3 Substanial Equivalence
ChlamydiaTrol Ag reagent is substantially equivalent to VIROTROL HIV-1 Ag (BK930033) unassayed virology control manufactured and distributed by Blackhawk
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BioSystems. Inc. in that they are both liquid unassayed control products which contain specific antigens at useful concentrations and are intended for use by laboratories to monitor reproducibility and performance of test procedures.
2.0 REAGENT DESCRIPTION AND STORAGE
ChlamydiaTrol Ag is a liquid quality control reagent classified under Multi Analyte Controls(assayed and unassayed).
ChlamydiaTrol Ag reagent is prepared from Chlamydia trachomatis elementary bodies extracted from infected mouse L cells grown in culture. Optimally infected cells are harvested and disrupted by sonication, and cellular debris is removed by centrifugation. Chlamydia trachomatis elementary bodies used in the preparation of ChlamydiaTrol Ag reagent have been rendered noninfectious by treatment with gamma radiation. The reagent contains human serum albumin(HSA), preservatives and stabilizers. HSA used to produce ChlamydiaTrol Ag reagents is prepared from normal human plasma which has been tested using licensed reagents and found to be non-reactive for Hepatitis B surface Antigen, antibodies to Human Immunodeficiency Virus Types 1 and 2 and antibodies to Hepatitis C Virus.
ChlamydiaTrol Ag reagents should be stored at 2℃ to 8℃ when not in use. When stored as directed, reagents are suitable for use for up to sixty days after opening or until the expiration date stated on the label. The expiration date for each reagent lot is established as twenty-four months from the date of manufacture.
3.0 PERFORMANCE
3.1 Expected Results
ChlamydiaTrol Ag reagents are unassaved controls and do not have assigned values. ChlamydiaTrol Ag reagents should be processed in the manner described for controls with in vitro diagnostic kits for the direct detection of Chlamydia trachomatis antigens and should be prepared and tested in conjunction with unknown specimens. Results may vary among different laboratories, among manufacturers and among different lots of the same test kit.
Representative levels of reactivity of two different lots of ChlamydiaTrol Ag reagents in commercially marketed in vitro diagnostic test kits are presented in Table 1. Results for each method were obtained by testing ChlamydiaTrol Ag reagents within a single location with a single lot of each reagent test kit in multiple test runs(n) performed by two or more operators.
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3.2 Reproducibility
The reproducibility of ChlamydiaTrol Ag reagent reactivity was evaluated with respect to within run and between run precision. Within run precision was determined by testing twenty replicates of the same sample in a single test run. Between run precision was determined from single test results of the sample in multiple test runs using the same reagent test kit lot. Results are summarized in Tables 2 and 3 and demonstrate coefficients of variation ranging between 2.1% and 19.9% for within run for between run precision. precision and and
4.0 STRESS TESTING
For the following studies, reactivity of ChlamydiaTrol Ag reagent was evaluated using the Abbott Chlamydiazyme Diagnostic Kit enzyme immunoassay(EIA). Similar studies were conducted for VIROTROL HIV-1 Ag reagent using the Abbott HIVAG-1 EIA and results reported in BK930033 demonstrate substantially equivalent performance of both products after exposure to stress conditions.
-
Elevated Temperature Studies 4.1
Reactivity of ChlamydiaTrol Ag reagent was evaluated after storage of unopened bottles at various temperatures. Results of two different lots of reagent stored at room temperature(20-25℃) and 37℃ are presented in Table 4 and demonstrate performance consistent with that of reagent stored at 2-8ºC. -
4.2 Freeze/Thaw Studies
Reagents were also tested after freezing at -20℃ and thawing at room temperature. Freeze/thaw cycles consisted of storage of the sample at -20℃ overnight followed by thawing at room temperature(20-25℃) until the solution reached room temperature. When multiple freeze/thaw cycles were performed, samples were then returned to -20℃ to repeat the cycle. Results of these studies are presented in Table 5 and indicate that freezing and thawing of reagents does not affect the reactivity. -
4.3 Open Vial Stability
Reactivity of two different lots of ChlamydiaTrol Ag reagent was evaluated at various time intervals after bottles were opened. Results of these studies are presented in Table 6 and demonstrate consistent performance of ChlamydiaTrol Ag reagents for time periods up to ninety days after opening. These data substantiate a claim for use of the reagent for up to sixty days after opening.
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CLINICAL EVALUATION ર.0
During the period from June, 1996 through May, 1997, two different lots of ChlamydiaTrol Ag reagent were evaluated by eight clinical investigators using commercially marketed test kits for the detection of Chlamydia trachomatis antigen. The purpose of these studies was to establish performance characteristics of ChlamydiaTrol Ag reagents during routine use in clinical laboratory settings and to assure their safety and effectiveness under normal conditions of use.
રે 1 Materials and Methods
The following commercial test systems were used in these studies:
CHLAMYDIAZYME Diagnostic Kit EIA(Abbott Laboratories) LCx Chlamydia trachomatis Assay(Abbott Laboratories) MicroTrak II Chlamydia EIA (Behring Diagnostics, Inc.)
All test procedures were carried out following instructions provided by the test kit manufacturer.
The recommended test procedure was to include ChlamydiaTrol Ag reagent in each test run by dispensing an aliquot into a sample tube and processing in the same manner as controls or calibrators provided with the test kit. Location of the ChlamydiaTrol Ag sample within a test run was determined by the user. Frequency of testing among sites varied depending upon total test specimen volume.
Results reported by each site were analyzed to determine the mean value, standard deviation and coefficient of variation. Analyses were performed on results obtained with ChlamydiaTrol Ag reagents as well as on values reported for controls or calibrators provided by the test kit manufacturer.
Results 5.2
Clinical evaluations at eight different laboratory sites were conducted using two different lots of ChlamydiaTrol Ag reagent and three different test methodologies. Results are presented in Tables 7 through 12 and include a summary of overall results for ChlamydiaTrol Ag as well as for controls or calibrators provided by the manufacturer of the test kit being used. Each result(n) for ChlamydiaTrol Ag represents a single determination whereas results for kit controls and calibrators represent averages of two or three determinations. Included in each table is a summary of overall results for each data set from each site. In addition, data collected were analyzed by separating results obtained with each commercial test kit lot for which three or more data points were reported. Differences in the total number of
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data points among laboratories occur as a consequence of variations in the total number of runs a site performed during the test period.
Results of ChlamydiaTrol Ag reagent reactivity in the Abbott Chlamydiazyme EIA procedure were reported by Sites 1 through 3 and are summarized in Tables 7 and 8. Consistent performance of ChlamydiaTrol Ag reagent at multiple sites is demonstrated by comparable mean absorbance values, sample to cutoff ratios(S/CO) and coefficients of variation obtained with multiple test kit lots.
Two different lots of ChlamydiaTrol Ag reagent were evaluated by Site 1. A comparison of overall results in Tables 7 and 8 for site 1 demonstrates equivalent performance of both reagent lots with respect to reactivity and reproducibility.
Performance of ChlamydiaTrol Ag reagent in the Behring MicroTrak II Chlamydia enzyme immunoassay was evaluated at Site 4. Results were collected using a single test kit lot and are summarized in Table 13.
Performance of a single lot of ChlamydiaTrol Ag reagent in the Abbott LCx Chlamydia trachomatis Assay procedure was evaluated at Sites 5 through 8. Results from each of the sites are presented in Tables 9 through 12 and demonstrate a high degree of consistency among the four laboratories. Overall mean values for the ChlamydiaTrol Ag S/CO results range from a minimum of 3.67 at Site 8 to a maximum of 4.51 at Site 7. Consistency of reagent performance among multiple test kit lots is also demonstrated with results obtained from data separated and analyzed for each test kit lot. A total of ten different test kit lots was used among the four different laboratories with duplication of three kit lot numbers among the sites. Comparable results for mean rate values, sample to cutoff ratios and coefficients of variation were obtained at all four sites and document perofrmance of the reagent in this test system..
ર :3 Discussion
Clinical evaluation of ChlamydiaTrol Ag reagents was carried out in eight different laboratories. During the study, results were collected for two different reagent lots using three different test methods for the detection of Chlamydia trachomatis antigen.
A summary of the overall results obtained with each of the different test methods is presented in Table 13. These results demonstrate similar reagent performance in all three laboratories which utilized the Abbott Chlamydiazyme enzyme immunoassay methodology and the same ChlamydiaTrol Ag lot. Consistent reproducibility of results among these laboratories is also evidenced by coefficients of variation ranging from 13.7% to 18.9%. Comparable results were also obtained for a single ChlamydiaTrol Ag reagent lot when tested in the Abbott LCx Chlamydia trachomatis
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assay, with coefficients of variation ranging from 5.0% to 9.5% among four different laboratories. Data presented here document reagent stability under field conditions and demonstrate consistent reagent performance among laboratories.
6.0 CONCLUSION
Product performance evaluation studies have been conducted by Blackhawk BioSystems, Inc. and by eight clinical investigators to validate performance of ChlamydiaTrol Ag reagent. The results of these studies document the safety and effectiveness of the reagent under normal conditions of use and also demonstrate that ChlamydiaTrol Ag reagent is substantially equivalent to similar currently marketed quality control products in that it has the same medical intended use with similar performance characteristics.
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Image /page/8/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carol Polito President Blackhawk BioSystems. Inc. 12945 Alcosta Boulevard San Ramon, California 94583
AUG 1 2 1997
Re: K972129 Trade Name: ChlamvdiaTrol Ag Regulatory Class: I Product Code: MJZ, MGM Dated: June 5, 1997 Received: June 6, 1997
Dear Ms. Polito:
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 to 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 Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Please note: this response to your premarket notification 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 regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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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Page 1 of 1
510(k) Number (if known): K972129
Device Name: ChlamydiaTrol Ag ________________________________________________________________________________________________________________________________________________
Indications For Use:
The ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Aq reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cien Puhs
(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number
Prescription Use ) (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.