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Liquichek Maternal Serum II Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Liquichek Maternal Serum II Control is prepared from defibrinated human plasma with added constituents of human origin, chemicals, stabilizers, and preservatives. The control is provided in liquid form for convenience.

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification for a Class I quality control material. For such devices, the primary "acceptance criteria" relate to demonstrating substantial equivalence to a legally marketed predicate device rather than specific clinical performance metrics like sensitivity or specificity.

The acceptance criteria for this device, the Liquichek Maternal Serum II Control, were primarily focused on demonstrating its suitability as an assayed quality control serum by comparing its characteristics and performance to a predicate device, the Lyphochek Maternal Serum Control (K984594). The key performance aspects evaluated were:

• Intended Use: The new device must have the same intended use as the predicate.
• Base Matrix: The fundamental composition should be comparable.
• Stability: The device must demonstrate adequate stability (thawed, opened, and shelf-life) to ensure its utility as a control material.
• Analytes: The device should contain the analytes relevant to its intended use and listed on the package insert, similar to or expanded from the predicate.

Table 1: Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is a comparison study to demonstrate substantial equivalence to the predicate device, along with stability studies to establish the shelf life and in-use stability of the new control material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify a numerical sample size for the test set in terms of cases or individual control units used for the comparison or stability studies. It states that mean values and ranges were derived from "replicate analyses," and "a representative sampling of this lot of product" was used. For stability, "real time stability studies" and "accelerated stability studies" were performed.
• Data Provenance: The studies were performed internally by Bio-Rad Laboratories or by "independent laboratories." The country of origin of the data is implied to be related to Bio-Rad Laboratories' operations, which is based in Irvine, California, USA. The studies are prospective in nature, as they are conducted on the newly manufactured device to establish its performance and stability claims.

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, not a diagnostic medical device that interprets patient data. Therefore, there is no "ground truth" in the clinical sense established by human experts. The "truth" for this device relates to its known analyte concentrations and its stability characteristics. The "value assignment" for the analytes is performed through analytical testing by the manufacturer and/or independent laboratories, not by expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As explained above, this device does not involve human interpretation of clinical data that would require an adjudication method. The performance is assessed through analytical measurements and comparison to predefined specifications (i.e., stability protocols, value assignment procedures).

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 a quality control material and not an AI-powered diagnostic device. Therefore, MRMC studies are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a biochemical control material, not an algorithm or software. Its performance is inherent to its chemical composition and stability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in the context of a quality control material refers to the assigned target values and acceptable ranges for each analyte within the control. This "truth" is established through replicate quantitative analytical measurements using validated methods by the manufacturer and/or independent laboratories, rather than expert consensus on clinical data or pathology. The stability ground truth is established through real-time and accelerated stability studies monitoring analyte concentrations over time under specified storage conditions.

8. The sample size for the training set

• Not Applicable. As a quality control material, this device does not involve machine learning or AI, and therefore, no "training set" is used. Its development and characterization rely on established laboratory manufacturing and analytical testing procedures.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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