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510(k) Data Aggregation
(28 days)
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800
Liquid Assayed Multiqual® Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Liquid Assayed Multiqual® Control is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin) chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Bio-Rad Laboratories Liquid Assayed Multiqual Control:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel device functions. Therefore, much of the requested information regarding detailed study design (like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not explicitly available in this summary. The provided text primarily discusses stability studies to support product claims.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the stability claims for the control material. The reported device performance is presented as the stability duration for various storage conditions.
| Acceptance Criteria (Claimed Stability) | Reported Device Performance (Achieved Stability) |
|---|---|
| Open Vial Stability: | |
| - General analytes: 14 days at 2-8°C | 14 days at 2-8°C (tightly capped) |
| - Total bilirubin: 10 days at 2-8°C | 10 days at 2-8°C |
| - LAP Arylamidase: 3 days at 2-8°C | 3 days at 2-8°C |
| Closed Vial Stability (Thawed): | |
| - General analytes: 30 days at 2-8°C | 30 days at 2-8°C (stored unopened) |
| - Total bilirubin values: may decrease | Values may decrease |
| - Alkaline Phosphatase activity: may rise | Activity may rise |
| - AST methods without pyridoxal-5-phosphate: must be stored frozen | Must be stored frozen |
| Shelf Life (Closed Vial, Frozen): | |
| - 3 years at -20°C or colder | 3 years at -20°C or colder |
Regarding the Study Information:
Since this is a 510(k) summary for a control material, the "study" referred to is primarily stability testing rather than a clinical effectiveness study. The intent is to demonstrate that the control material maintains its integrity and stability under specified conditions for its intended use, which is "to monitor the precision of laboratory testing procedures."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary. "Real time studies will be ongoing to support the shelf life of this product" suggests a prospective component, but the summary primarily describes historical data that has already been collected. The studies were performed by Bio-Rad Laboratories, located in Irvine, California, USA, so presumably the data originates there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a quality control material, the "ground truth" for stability is typically determined by analytical testing methods and comparison to initial formulated values, not expert consensus as in a diagnostic imaging study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Stability studies rely on laboratory measurements and statistical analysis, not expert adjudication.
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
- MRMC Study: No, this is not applicable. This device is a liquid assayed control material, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For stability studies of control materials, the "ground truth" is typically the initial analytical values of the components within the control at the time of manufacture, and then subsequent measurements are compared against these initial values to determine if they remain within acceptable ranges over time and under various storage conditions. This is based on analytical testing and established analytical methods, not expert consensus or pathology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI or machine learning device. The studies are related to the stability of the manufactured product.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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