(85 days)
Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.
Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals, preservatives, and stabilizers have been added.
The provided text describes a "Summary of Safety and Effectiveness" for the Quest Diagnostics Serum Chemistry Control, a quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI, human readers, or image analysis. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted or deduced from the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K033387). The performance is characterized by its intended use, form, matrix, other ingredients, and stability claims, which are compared to the predicate.
| Acceptance Criteria Category | Predicate Device Performance | New Device Performance | Notes |
|---|---|---|---|
| Intended Use | Quality control serum to monitor precision of automated and manual testing procedures. | Quality control serum to monitor precision of automated and manual testing procedures. | Similar |
| Form | Liquid | Liquid | Similar |
| Matrix | Human serum based | Human serum based | Similar |
| Other Ingredients | Stabilizers and preservatives | Stabilizers and preservatives | Similar |
| Open Vial Claim | 30 days at 2-8°C | 30 days at 2-8°C | Similar |
| Shelf Storage Claim (Unopened) | Max 2 years at -10°C to -20°C | Max 2 years at -20°C to -70°C (with ongoing real-time studies) | New device has a different, broader temperature range for long-term storage. |
| Alternate Storage Claim (Unopened) | None | 6 months at -10°C to -20°C | New device has an additional alternate storage claim. |
| Analytes | Contains 30 analytes (listed). Does not contain LDL. | Contains 31 analytes (listed). Includes LDL. | New device has an added claim for LDL. |
Study Information
The document describes stability studies as the primary supporting data for the device's claims.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the sample size (number of control units or replicates) used for the stability studies.
- The data provenance is from Bio-Rad Laboratories, Irvine, California, USA.
- The stability studies are described as "Real time studies will be ongoing," which implies they are prospective for the shelf life claim, while the initial open-vial and alternate stability claims would have sufficient data to be submitted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. This is a quality control material for chemical testing, not a diagnostic device requiring expert interpretation of results. The "ground truth" for chemical controls is established through rigorous laboratory testing against reference methods or certified reference materials, not expert consensus in the typical medical imaging sense.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this type of adjudication is not relevant for chemical control materials. Quality control performance is assessed against established statistical limits and analytical targets.
-
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 device is a quality control material for laboratory instruments, not an AI-assisted diagnostic tool or a human-read diagnostic test.
-
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 intrinsic to the chemical stability and composition of the control material.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a quality control material like this, the "ground truth" for its performance (e.g., stability over time) would be established by analytical measurements using validated laboratory methods and potentially comparison to certified reference materials or industry standards. The document states "All supporting data is retained on file at Bio-Rad Laboratories," indicating internal validation.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set is involved.
§ 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.