(60 days)
The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G_2 (IGG_2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), Transferrin (TRF) methods
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid buffered based product containing multiple analytes (proteins derived from human source). The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required). The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL. Anti-streptolysin-O (ASO), Alpha-1-Antitrypsin (AAT), Prealbumin (PREALB), Rheumatoid Factor (RF), Immunoglobulin A 2, (IGA 2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M 2 (IGM 2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Transferrin (TRF), and Alpha-Acid-Glycoprotein (AAG) are value assigned for ADVIA 1650 Chemistry systems. In addition the calibrator also contains Ferritin and CRP with no specific value assignment on ADVIA Chemistry systems at this time.
This document is a 510(k) summary for a calibrator device, not an AI/ML powered diagnostic device. Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of medical device submission.
Calibrators are used to standardize the measurements of analytical instruments. Their performance is typically assessed by demonstrating that they accurately establish a calibration curve for the specified analytes on the intended instrument, and that the calibrated system can then accurately measure controls and patient samples. The primary focus for a calibrator 510(k) is often on demonstrating substantial equivalence to a predicate device in terms of intended use, formulation, analytes quantified, and performance characteristics like stability.
However, I can extract the information relevant to the device's characteristics and the comparison made.
Device Name: ADVIA® Chemistry Liquid Specific Protein Calibrator
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense as one would for a diagnostic test (e.g., sensitivity/specificity thresholds). Instead, the "performance" for a calibrator is largely demonstrated by showing substantial equivalence to a legally marketed predicate device. The core "performance" demonstrated here is that the new calibrator is functionally equivalent to the predicate for calibration on the specified instruments and analytes.
| Item | New Device Performance (ADVIA® Chemistry Liquid Specific Protein Calibrator) | Predicate Device Performance (Randox Liquid Protein Calibrators - K061056 & K031608) |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for AAG, AAT, ASO_2, C3, C4, HAPT, IGA_2, IGG_2, IGM_2, PREALB, RF, TRF methods. | Similar intended use for calibration of various protein assays on Clinical Chemistry and Immunoassay systems, including ASO, C3, C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, Transferrin, AAT, and RF. |
| Formulation / Analytes Present | Anti-streptolysin-O, Alpha-1-Antitrypsin, Prealbumin, Rheumatoid Factor, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Complement C3, Complement C4, Haptoglobin, Transferrin, Ferritin, Alpha-acid-glycoprotein, CRP. | Same analytes present. |
| Measured Analytes (value assigned) | Anti-streptolysin-O, Alpha-1-Antitrypsin, Prealbumin, Rheumatoid Factor, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Complement C3, Complement C4, Haptoglobin, Transferrin, Alpha-acid-glycoprotein. (Ferritin and CRP present but not value assigned on ADVIA Chemistry systems at this time). | ASO, AAT, Prealbumin, RF, IgA, IgG, IgM, Complement C3, Complement C4, HAPT, Transferrin, Alpha-acid-glycoprotein, Ferritin, CRP. |
| Instrument Compatibility | ADVIA® Chemistry Systems | Clinical Chemistry and Immunoassay systems, including numerous specific instruments listed (e.g., Abbott, Ace, Bayer Advia, Dade Dimension, Hitachi, Kone, AU series, Selectra, Synchron, ILAB, RX, Cobas). |
| Traceability for AAG | International Reference Material CRM 470 | Same. |
| Matrix | Buffered base | Same. |
| Analyte Source | Derived from human source | Same. |
| Number of Levels | Six (the lowest level is a zero-level) | Same. |
| Fill Volume | 1.0 mL each vial | Same. |
| Stability | 24 months – shelf-life | Same. |
Key takeaway for "acceptance criteria": The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device. The detailed comparison table shows that across all critical parameters (intended use, composition, analytes, matrix, and stability), the new device is either identical or sufficiently similar to the predicate to be considered substantially equivalent.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a test set with an 'n' number of cases. For a calibrator, "testing" typically involves technical validation on the intended instrument. This would involve running the calibrator multiple times to establish a calibration curve, and then running quality control materials and potentially patient samples calibrated by the new device to ensure accurate results. The document does not provide specifics on the number of runs, samples, or sites for these validation activities.
- Data Provenance: The document does not specify the country of origin of testing data. It is a submission by Siemens Healthcare Diagnostics Inc., located in Tarrytown, NY, USA. The study design (clinical/retrospective/prospective) is not applicable in the way it is for an AI/ML diagnostic. This is a technical performance validation of a calibrator.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a calibrator, "ground truth" relates to the assigned values of the analytes. These values are established through rigorous analytical methods, often traceable to international reference materials (as noted for AAG, "International Reference Material CRM 470"). It's a scientific and metrological process, not expert consensus as in image interpretation.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts in diagnostic studies, particularly for subjective interpretations (e.g., radiology). This is not relevant for a calibrator.
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 not an AI/ML diagnostic device, nor is it a device that is read or interpreted by human readers in the context of diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a calibrator, not an algorithm.
7. The type of ground truth used:
- Reference Material Values / Analytical Assignment: For calibrators, the "ground truth" (or target value) for each analyte level is established through highly accurate analytical methods, often by comparing to or using international reference materials (e.g., "International Reference Material CRM 470" for AAG). This is a metrological ground truth, not pathology, expert consensus, or outcomes data in the diagnostic sense.
8. The sample size for the training set:
- Not Applicable. This is a calibrator, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.