(93 days)
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection, and to monitor response during and post-therapy in adult patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
The Premier Platinum HpSA test utilizes polyclonal anti-H. pvlori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.
Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Premier Platinum HpSA device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical target format for the Premier Platinum HpSA device itself. Instead, it justifies substantial equivalence by comparing its performance against a predicate device (Meretek UBT). The acceptance is implied by the comparable or superior performance relative to the predicate.
Here's a table comparing the Premier Platinum HpSA's performance to its predicate:
| Criterion | Premier Platinum HpSA (Reported Performance) | Meretek UBT (Predicate Performance) |
|---|---|---|
| Sensitivity | 94.7% (74.0-99.0%) | 85.0% (62.1-96.8%) |
| Specificity | 96.1% (88.9-99.2%) | 96.1% (88.9-99.2%) |
| Correlation | 95.8% (89.6-98.8%) | 93.8% (86.9-97.7%) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set during the performance validation. It provides confidence intervals for Sensitivity, Specificity, and Correlation for both the Premier Platinum HpSA and the predicate device, which implies a certain sample size was used to achieve those intervals, but the exact number is not given.
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test for detecting H. pylori antigens in stool, interpreted visually or spectrophotometrically, not an imaging device requiring human reader interpretation in the same way an MRMC study would apply. The comparison is between two diagnostic assays, not between human readers with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The reported Sensitivity, Specificity, and Correlation for the Premier Platinum HpSA (94.7%, 96.1%, and 95.8% respectively) represent the standalone performance of the algorithm/assay itself.
7. Type of Ground Truth Used
The document states "Performance vs. Reference Methods" when presenting the sensitivity, specificity, and correlation. While not explicitly defined, "Reference Methods" in the context of diagnostic tests typically refer to established, highly accurate diagnostic tests or a combination of clinical outcomes and other diagnostic modalities (e.g., histology/pathology, culture, or a consensus of multiple established clinical tests). Given this is a diagnostic test for H. pylori, common reference methods include histology, culture, or other validated breath tests/serology in combination with clinical presentation.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This is typical for traditional in-vitro diagnostic (IVD) assays developed without machine learning or AI components in the modern sense. The "training" and optimization of such assays usually refer to laboratory development and optimization steps, not a distinct "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how its ground truth was established.
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Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier Platinum HpSA
K98325J
510(k) Summary A.
Identification Information
Submitter's Information:
Submitter's Name and Address:
Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244
Phone Number: 1-800-543-1980
Contact Person: Allen D. Nickol, PhD Director of Clinical and Regulatory Affairs
Date Summary Prepared: September 14, 1998
Name of Device: Premier Platinum HpSA
Classification Name: Campylobacter pylori, 83LYR
Predicate Equivalent Device: Meretek UBT
Description of Device:
The Premier Platinum HpSA test utilizes polyclonal anti-H. pvlori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.
Intended Use:
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection, and to monitor response during and post-therapy in adult patients. Accepted medical practice recommends that testing by any current method, to confirm eradication. be done at least four weeks following completion of therapy.
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Comparison with Predicate Device:
The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the Premier Platinum HpSA test and the Urea Breath Test (UBT). The differences in technology do not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Intended Use | Detection of H. pylori antigens in patientstool | Detection of H. pylori associated ureaseactivity in breath specimens |
|---|---|---|
| Results | Qualitative | Qualitative |
| Specimen Required | Stool | Before and after breath specimens |
| Technology | Sandwich Enzyme Immunoassay | H. pylori urease catalyzed conversion of$^{13}C-urea$ to $^{13}CO_2$ and ammonia. $^{13}CO_2$ isdetected by GC-mass spectroscopy |
| Level of Skill Required | Laboratory Technician | Nurse or physician to administer test andcollect specimens. G/C Mass Spec andcertified lab / technician to performanalysis. |
| Function | 1. Specimen diluted 1/3 and added towell containing rabbit anti- H. pyloricapture Ab.2. One drop HRP-conjugated detectionAb added.3. Incubation 1 hr at roomtemperature.4. Wash 5 times.5. Add 2 drops substrate.6. Incubate 10 minutes at roomtemperature.7. Add one drop stop solution and readvisually or spectrophotometrically | 1. Baseline breath specimens are takenin duplicate.2. Pudding and urea solution areingested. 30 minute metabolism.3. Test breath specimens are taken induplicate.4. Samples are mailed in for analysisby licensed laboratory.5. Results reported as ratio of Deltaover Baseline (DOB) |
| Interpretation | Pos/Neg read visually orspectrophotometrically. Fixed cut-off0.140 single wavelength (450nm) or0.100 dual wavelength (450-630nm) | DOB ≥ 2.4: PositiveDOB < 2.4: Negative |
| Performance vs.Reference MethodsSensitivitySpecificityCorrelation | 94.7% (74.0-99.0%)96.1% (88.9-99.2%)95.8% (89.6-98.8%) | 85.0% (62.1-96.8%)96.1% (88.9-99.2%)93.8% (86.9-97.7%) |
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEC 1 7 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Allen D. Nickol. Ph.D. Director of Clinical and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244
Re: K983255 Trade Name: Premier Platinum HPSA Regulatory Class: I Product Code: LYR Dated: December 1, 1998 Received: December 2, 1998
Dear Dr. Nickol:
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 Regulations, 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 OS 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 CLIA 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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E. Indications for Use Statement
983255 510(k) Number (if known):
Device Name: Premier Platinum HpSA
Indications For Use:
్లో స్టే
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection, and to monitor response during and post-therapy in adult patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woodley Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983255
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).