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510(k) Data Aggregation
(64 days)
REMEL, L.P.
REMEL's Bile Esculin Azide Agar w/ 6 μg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overoome the inhibitory effects of the medium.
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The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about clinical study results, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Device Name: Remel Bile Esculin Azide Agar w/6 µg/ml Vancomycin
- Regulatory Class: II, Product Code: JSO
- Indications for Use: Plated medium for qualitative procedures, as a selective and differential medium for the primary isolation of vancomycin-resistant enterococci from surveillance cultures. It explicitly states it is not intended for antimicrobial susceptibility testing and recommends confirmation of vancomycin resistance by an approved method.
- FDA's determination: The device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the input text. The text does not describe a study that proves the device meets acceptance criteria, nor does it list any specific acceptance criteria or performance metrics.
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(101 days)
REMEL, L.P.
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(66 days)
REMEL, L.P.
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(187 days)
REMEL, L.P.
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(260 days)
REMEL, L.P.
Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies. The results of these studies are summarized in the attached Technical Insert. This device is effective when tested under the conditions for its Each test kit contains a technical insert which intended use.
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Acceptance Criteria and Device Performance for RPR Liquid Controls
This submission pertains to the RPR Liquid Controls device for which "reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies." The submission indicates that "relative sensitivity and specificity data" are provided within the accompanying technical insert, but the specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text.
Based on the provided data tables, the study appears to be a comparative study of the REMEL RPR CARD TEST CONTROLS against Reference Positive and Negative Controls. The performance is assessed by comparing the qualitative results (Reactive-R/moderately Reactive-Rmod/Non-Reactive-N or NR) of the REMEL controls against the established Reference controls.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria are inferred from the study design where the REMEL controls are expected to match the Reference controls. The provided data demonstrates this matching.
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary from data tables) |
|---|---|
| Positive Control Performance: REMEL Positive Control (RPR CARD TEST CONTROLS) should consistently show a "Reactive" (R) or "Moderately Reactive" (Rmod/mR/me) result. | At both testing sites (Michigan Department of Public Health and UTex), the REMEL Positive Control consistently showed a "Reactive" (R) or "Moderately Reactive" (Rmod, mR, me, R4+) result, matching the Reference Positive Control. |
| Negative Control Performance: REMEL Negative Control (RPR CARD TEST CONTROLS) should consistently show a "Non-Reactive" (N or NR) result. | At both testing sites, the REMEL Negative Control consistently showed a "Non-Reactive" (N or NR) result, matching the Reference Negative Control. |
| Agreement with Reference Controls: REMEL Positive and Negative Controls should consistently provide results that match the corresponding Reference Positive and Negative Controls. | 100% agreement between the REMEL RPR CARD TEST CONTROLS and the Reference Controls for both positive and negative controls across all recorded dates and testing sites. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Michigan Dept. of Public Health Site: The data table shows recorded results for 23 distinct dates for both positive and negative controls. Each date represents a test run.
- UTex Site: The data table shows recorded results for 15 distinct dates for both positive and negative controls. Each date represents a test run.
- Total Test Observations: 38 test observations (dates) across two sites for both positive and negative controls.
- Data Provenance: The data comes from two distinct sites:
- Michigan Dept. of Public Health, with H. Stiefel as the Principal Investigator (PI).
- UTex, with Hartwell as the Principal Investigator (PI).
The data appears to be prospective, as it's dated chronologically from July/August 1995 to October 1995, indicating ongoing testing of the controls.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided document does not mention the use of experts or their qualifications for establishing ground truth for this particular study. This study is for RPR Liquid Controls, which are themselves reference materials used to validate the performance of an RPR CARD TEST. The "Reference Pos Crtl" and "Reference Neg Crtl" serve as the ground truth in this context, representing established standards for positive and negative reactivity.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). Since the comparison is between a test control and a reference control, the result is likely a direct match/non-match rather than requiring expert consensus for interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study evaluates the performance of laboratory controls, not the interpretation by human readers, and therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable here.
6. Standalone Performance (Algorithm Only)
This device (RPR Liquid Controls) is a laboratory control material, not an algorithm or an AI-powered device. Therefore, a standalone (algorithm only) performance assessment, as typically understood for AI, is not applicable. The data presented shows the performance of the liquid controls themselves when used in a standard RPR card test.
7. Type of Ground Truth Used
The ground truth used in this study is based on established "Reference Positive Controls" and "Reference Negative Controls." These are presumably well-characterized and validated materials that are known to elicit a specific (positive or negative) reaction in the RPR test. This is a form of reference standard (or gold standard) truth based on known characteristics of the samples.
8. Sample Size for the Training Set
The document does not mention any training set. This is expected as the RPR Liquid Controls are a reagent/control product, not a machine learning model that requires training. The data presented is for validation/verification of the control's performance.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this product, this question is not applicable.
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(259 days)
REMEL, L.P.
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This K955136 submission is for the RPR Card Test Kit, a device for detecting Treponema pallidum infection. The provided documents describe the performance characteristics of two RPR antigens (Ag#1 and Ag#2) compared to existing RPR antigens.
While the documents indicate that the RPR Card Test Kit is "effective when tested under the conditions for its intended use" and includes "relative sensitivity and specificity data," they do not explicitly state quantitative acceptance criteria or provide a table of performance against such criteria. The focus is on comparing the REMEL manufactured antigens to existing and CDC-approved antigens.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit, quantitative acceptance criteria are not provided, we can infer that the general acceptance criterion was "satisfactory performance" as judged by the CDC and consistency with comparator tests and clinical history.
| Acceptance Criterion (Inferred) | Reported Device Performance (Ag#1 - REMEL manufactured) | Reported Device Performance (Ag#2 - LEE Labs manufactured) |
|---|---|---|
| Overall Performance / Satisfactory Rating (by CDC) | "Satisfactory" by the CDC. | "Satisfactory" by the CDC. |
| Consistency with Comparator RPR Antigen (BD RPR for Ag#1 & Ag#2, Difco USR for Ag#2) | No significant discrepancies compared to BD RPR antigen at the University of Texas. | Generally consistent with BD RPR antigen at the University of Texas and Difco USR antigen at Michigan Dept. of Health. Some reactive samples at U. of Texas were nonreactive with Ag#2 and reactive (undiluted endpoint titer) with BD Ag; however, this was not seen as a significant discrepancy at the Michigan site and was consistent with USR. |
| Consistency in Titer (for reactive samples) | No statistically significant difference in performance (titer) compared to BD RPR for reactive samples. | Not explicitly stated for titer, but the overall performance was considered consistent. |
| Consistency with MHA-TP (for reactive samples) | Results consistent with MHA-TP (for all reactives). | Results consistent with MHA-TP (for all reactives). |
| Consistency with Clinical History (stage of infection, treatment history) | Reactive results consistent with history of treatment and staging of illness. | Reactive results consistent with history of treatment and staging of illness. |
| Impact of Patient Gender on Outcome | Patient gender did not affect the outcome of the tests. | Patient gender did not affect the outcome of the tests. |
| Repeatability/Reproducibility | Not explicitly stated for Ag#1. | "Repeat testing of the same samples with the same material at the U. of Texas yielded the same results" for discrepant samples, implying good internal consistency. Michigan site also showed consistency with known results despite initial U. of Texas discrepancies. |
| Relative Sensitivity and Specificity | "Each insert contains information on the limitations and the performance characteristics of the test (including relative sensitivity and specificity data) when used according to the directions." | "Each insert contains information on the limitations and the performance characteristics of the test (including relative sensitivity and specificity data) when used according to the directions." |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the test sets are not explicitly stated in terms of total number of specimens. The text mentions "many of the reactive samples" were titered or had clinical history documented. For Ag#2, a subset of "U. of Texas discrepant samples along with 12 known reactive samples and 12 known nonreactive samples" were sent blinded to Michigan.
- Data Provenance: The studies were conducted at the University of Texas and the Michigan Department of Public Health within the United States. The data appears to be retrospective, using clinical samples, based on the mention of "patient genders," "stage of infection with Treponema pallidum and history of treatment."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth appears to be established through a combination of:
- Comparator tests: BD RPR antigen, MHA-TP, Difco USR antigen. These are established laboratory tests.
- Clinical history: "Stage of infection with Treponema pallidum and history of treatment."
The individuals involved in the evaluation were:
- Dr. Beth Hartwell at the University of Texas.
- Mr. Harlan Stiefel at the Michigan Department of Public Health.
- The CDC (for initial evaluation and "satisfactory" determination).
Their specific qualifications (e.g., number of years of experience in serology or infectious disease diagnostics) are not detailed, beyond their institutional affiliations. It is implied that they are experts in their respective fields capable of conducting and evaluating these tests.
4. Adjudication Method
The adjudication method is not explicitly stated as a formal process like "2+1" or "3+1." The evaluation involves comparative testing against established methods (BD RPR, Difco USR, MHA-TP) and consistency with clinical records. Discrepancies were noted and, in the case of Ag#2, a subset of discrepant samples along with known samples were sent "blinded" to the Michigan site for re-evaluation and verification, indicating a form of external review. However, a structured adjudication protocol for the entire test set is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done to assess human reader improvement with or without AI assistance. This device is a diagnostic kit, not an AI-assisted interpretation tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This request is not applicable to the RPR Card Test Kit. This is a manual diagnostic test kit, not an algorithm or AI system. Its performance inherently involves human interpretation of results (e.g., flocculation). The study assesses the performance of the antigen/reagent, not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth used is a combination of:
- Expert Consensus/Established Comparator Tests: Performance against "Satisfactory" ratings by the CDC, BD RPR antigen, Difco USR antigen, and MHA-TP (Microhemagglutination Assay for Treponema pallidum). MHA-TP is a treponemal-specific test, often used for confirmation of RPR results.
- Outcomes/Clinical Data: "Stage of infection with Treponema pallidum and history of treatment." This clinical information serves as a crucial part of establishing the true status of the patient (e.g., reactive RPR should align with active infection or treated infection history).
8. Sample Size for the Training Set
No explicit training set is mentioned. For diagnostic kits like this, the "training" equivalent would typically involve formulation and initial in-house testing to optimize the antigen and kit components. The provided text describes the evaluation of already formulated antigens (Ag#1 and Ag#2) that were deemed "Satisfactory" by the CDC prior to the reported comparison studies.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned in the context of algorithm development, this question is not directly applicable. However, the "ground truth" for the initial development and "satisfactory" determination by the CDC would likely involve:
- Known positive and negative samples (well-characterized clinical specimens).
- Comparison to standard reference preparations or established, validated RPR tests.
- Correlation with other serological tests for syphilis (e.g., FTA-ABS, MHA-TP) and clinical diagnosis.
The "satisfactory" rating from the CDC for both antigens before their use in the reported studies implies that a ground truth was established for the antigens themselves, but the details of that establishment are not provided within these documents.
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(61 days)
REMEL, L.P.
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(61 days)
REMEL, L.P.
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(63 days)
REMEL, L.P.
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(108 days)
REMEL, L.P.
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