(93 days)
K98325J
Not Found
No
The device description details a standard enzyme immunoassay (EIA) procedure involving chemical reactions and visual or spectrophotometric interpretation, with no mention of AI or ML technologies.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for the qualitative detection of Helicobacter pylori antigens in human stool to aid in diagnosis and monitor therapy, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Test results are intended to aid in the diagnosis of H. pylori infection."
No
The device description clearly outlines a laboratory-based enzyme immunoassay (EIA) procedure involving physical reagents, microwells, and spectrophotometric or visual interpretation, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Premier Platinum HpSA EIA is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laboratory procedure involving the analysis of a human sample (stool) using reagents and equipment (microwells, antibodies, substrate, spectrophotometer) to obtain a result. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance metrics like Sensitivity and Specificity, which are standard for evaluating the accuracy of diagnostic tests, further supports its classification as an IVD.
N/A
Intended Use / Indications for 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.
Product codes
LYR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Laboratory Technician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance vs. Reference Methods
Sensitivity: 94.7% (74.0-99.0%)
Specificity: 96.1% (88.9-99.2%)
Correlation: 95.8% (89.6-98.8%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 94.7%
Specificity: 96.1%
Predicate Device(s)
K98325J
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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 patient
stool | Detection of H. pylori associated urease
activity 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. $^{13}CO_2$ is
detected by GC-mass spectroscopy |
| Level of Skill Required | Laboratory Technician | Nurse or physician to administer test and
collect specimens. G/C Mass Spec and
certified lab / technician to perform
analysis. |
| Function | 1. Specimen diluted 1/3 and added to
well containing rabbit anti- H. pylori
capture Ab.
2. One drop HRP-conjugated detection
Ab added.
3. Incubation 1 hr at room
temperature.
4. Wash 5 times.
5. Add 2 drops substrate.
6. Incubate 10 minutes at room
temperature.
7. Add one drop stop solution and read
visually or spectrophotometrically | 1. Baseline breath specimens are taken
in duplicate.
2. Pudding and urea solution are
ingested. 30 minute metabolism.
3. Test breath specimens are taken in
duplicate.
4. Samples are mailed in for analysis
by licensed laboratory.
5. Results reported as ratio of Delta
over Baseline (DOB) |
| Interpretation | Pos/Neg read visually or
spectrophotometrically. Fixed cut-off
0.140 single wavelength (450nm) or
0.100 dual wavelength (450-630nm) | DOB ≥ 2.4: Positive
DOB