(211 days)
The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, such as serum, plasma, or urine. It is an "open" system, which can use a variety of commercially manufactured reagents, such as, but not limited to Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
The provided text is a 510(k) premarket notification summary and the FDA's response letter for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER. It establishes "substantial equivalence" to a predicate device, the Synermed IR® 200.
However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested. The "Performance" section within the Summary of Safety and Effectiveness only states: "Substantially equivalence was established in comparative studies. It was concluded from these results that this product is safe and effective." This is a general statement, not a detailed report of performance against quantitative criteria.
The information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is typically found in the full 510(k) submission, not in this public summary document. The summary only attests that such studies were performed and deemed sufficient to show substantial equivalence.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document only states that "Substantially equivalence was established in comparative studies," implying that the device's performance was comparable to the predicate device, Synermed IR® 200, across various analytes. Specific quantitative criteria and performance values are not detailed. | Not specified in the provided document. The document does not provide specific metrics like accuracy, precision, sensitivity, or specificity. It only states that the device was found to be "safe and effective" and "substantially equivalent" to the predicate. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified in the provided document. It refers generally to "comparative studies" but provides no details on their design or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This device is an automated clinical chemistry analyzer. The "ground truth" for chemical measurements would typically be established through reference methods or certified standards, not expert reader consensus. The document does not mention experts establishing a ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations (e.g., image reading), not for automated chemical analyzers where results are quantitative.
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. The device is a standalone automated clinical chemistry analyzer, not an AI-assisted diagnostic tool for human readers. Such a study would not be relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The ANALETTE™ is described as an "automated clinical chemistry analyzer for the analysis of analytes in solution." Its performance is inherently standalone for quantitative measurements. The "comparative studies" mentioned would have evaluated its direct measurements against a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Reference Methods/Standards: For an automated clinical chemistry analyzer, the ground truth would typically be established by validated reference methods, certified reference materials, or comparison to results from highly accurate lab instruments. The document does not explicitly state the method, but this is the standard for such devices.
8. The sample size for the training set
- Not applicable/Not specified. This device is a traditional automated chemistry analyzer, not an AI/ML device that requires a "training set" in the machine learning sense. Its operation is based on established chemical principles and pre-programmed algorithms for measurement and calculation.
9. How the ground truth for the training set was established
- Not applicable. As noted above, this is not an AI/ML device that uses a "training set."
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(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 § 862.9.