(79 days)
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in coniunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).
For in vitro diagnostic use only.
VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.
The quantitative measurement of antistreptolysin O is performed using the VITROS Chemistry Products ASO Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 28 and VITROS Chemistry Products FS Calibrator 1 on VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products Calibrator Kit 28 is an aqueous solution containing processed human serum, protein, inorganic salt, and preservative.
VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline).
VITROS Chemistry Products ASO/RF Performance Verifiers contain two levels of lyophilized assayed controls for use in monitoring performance of VITROS ASO and RF Reagents on VITROS 5,1 FS Chemistry Systems. These controls are prepared from processed human serum to which purified human proteins, bovine serum albumin and preservative have been added. These controls are reconstituted with VITROS Chemistry Products FS Reconstitution Diluent that contains processed water.
The provided text is a 510(k) summary for in-vitro diagnostic devices (calibrators and performance verifiers). It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a medical imaging device or AI algorithm might. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document.
However, I will extract the information that is present and indicate where the requested information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format typical for a clinical study comparing an AI device's output to a ground truth. Instead, the "acceptance criterion" is effectively substantial equivalence to existing predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II) | The submission argues that the new devices (VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products ASO/RF Performance Verifiers I and II) are substantially equivalent to the predicate devices. The FDA concurred with this determination, as indicated by the clearance letter (K052645). |
The tables provided (Tables 1, 2, and 3) detail similarities and differences in device characteristics (intended use, fluid matrix, analyte levels, analyte, traceability, format) between the new devices and their respective predicates. These comparisons serve as the basis for the declaration of substantial equivalence. For example:
- VITROS Calibrator Kit 28 (New) vs. VITROS Calibrator Kit 16 (Predicate):
- Intended Use: Differs (ASO vs. RF calibration)
- Fluid Matrix: Same (aqueous solution)
- Analyte Levels: Differs (one level vs. five levels)
- Analyte: Differs (ASO vs. RF)
- Traceability: Differs (NIBSC 97/6621 vs. NIBSC 64/22)
- Format: Same
- VITROS FS Calibrator Kit 1 (New) vs. VITROS FS Calibrator Kit 1 (Predicate):
- Intended Use: Similar (calibration of VITROS 5,1 FS systems, but new device supports additional calibrator kits)
- Fluid Matrix: Same
- Analyte Levels: Same
- Analyte: ASO (for new device's context) vs. RF (for predicate's context) - Note: The table lists ASO for the new device and RF for the predicate, which is slightly confusing as FS Calibrator 1 is a general diluent/calibrator component. The text clarifies its use with various kits.
- Traceability: Differs (NIBSC 97/6621 vs. NIBSC 64/22)
- Format: Same
- VITROS ASO/RF Performance Verifiers I and II (New) vs. VITROS RF Performance Verifiers I and II (Predicate):
- Intended Use: Similar (monitoring performance, but new device includes ASO)
- Fluid Matrix: Same
- Analyte Levels: Same
- Analyte: Differs (ASO and RF vs. RF)
- Format: Same
The "reported device performance" is not a set of quantitative metrics from an independent study, but rather the claim that these devices perform equivalently to the predicate devices for their intended use, based on their design and components.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an algorithm or imaging study. The evaluation performed is a comparison of device characteristics for substantial equivalence. There is no mention of a sample size of patient data or clinical samples tested for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission (IVD calibrators/controls). There is no "ground truth" established by experts in the context of reviewing images or clinical data. The "ground truth" for the calibrators and verifiers themselves would be established through their manufacturing and quality control processes to ensure their stated values and stability.
4. Adjudication Method for the Test Set
Not applicable. No "adjudication method" is described as there is no test set in the sense of clinical cases needing expert review.
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
Not applicable. This is an IVD device submission for calibrators and controls, not an AI or imaging diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The devices are reagents/calibrators used with an automated chemistry system (VITROS 5,1 FS Chemistry Systems). They are not standalone algorithms or software-only devices.
7. The Type of Ground Truth Used (Expert Concensus, Pathology, Outcomes Data, etc.)
For IVD calibrators and controls, the "ground truth" for their values and performance characteristics is established through analytical validation processes, often traceable to international reference standards (e.g., NIBSC standards mentioned: NIBSC 97/6621 for ASO, NIBSC 64/22 for RF). This involves manufacturing controls, stability studies, and performance testing to ensure they accurately calibrate and monitor the assay. It is not an expert consensus on clinical findings, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as these are physical diagnostic reagents, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 866.3720
Streptococcus spp. exoenzyme reagents.(a)
Identification. Streptococcus spp. exoenzyme reagents are devices used to identify antibodies toStreptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.