(46 days)
N/T Protein Control LC is intended for use as an assayed accuracy and precision control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and a - microglobulin in urine, albumin and total protein in urine and CSF using the BN™ Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime System.
N/T Protein Control LC is a lyophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.
The provided text describes a 510(k) Notification-Modification for Dade Behring Inc.'s N/T Protein Control LC. This is a quality control material, not a medical device in the typical sense that would diagnose or treat a condition, and as such, the performance criteria and supporting data differ significantly from what would be expected for an AI-powered diagnostic device.
Therefore, many of the typical questions for AI acceptance criteria (like effect size with AI assistance, expert qualifications, adjudication methods, training set details) are not applicable to this type of device.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability (unopened) | Stable for at least 24 months at +2° to +8° C |
| Stability (reconstituted) | Stable for at least 14 days at +2º to +8º C |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation in the way a diagnostic device would typically have. The stability was evaluated "according to in-house protocols," implying internal testing rather than a large, independent clinical test set.
- Data Provenance: The stability evaluation was done "according to in-house protocols" by Dade Behring Marburg GmbH and Dade Behring Inc. This indicates internal, company-generated data. It's likely prospective testing conducted in a laboratory setting. No country of origin for external data is mentioned as it's an internal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a quality control material. Ground truth for its performance would be established by analytical methods and reference standards for stability, not by expert consensus on clinical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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-powered diagnostic device; it's a quality control material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device. Its performance is inherent to its chemical composition and manufacturing control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Standards/Internal Protocols: The ground truth for stability would be based on established analytical chemistry methods and internal stability protocols, comparing the control's performance over time against its initial validated values using specified instrumentation (BN™ Systems and TurbiTimeSystem).
8. The sample size for the training set
- Not Applicable. This product is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.