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The Wash Concentrate is diluted to prepare Wash Solution, a dilute solution of wetting agents and preservatives. It is formulated to serve as a reagent diluent and a wash solution for the SYNCHRON CX 3 and all of its chemistries. The diluent allows the use of concentrated reagents that exhibit improved open stability over more dilute reagents.

The Wash Concentrate is diluted to prepare Wash Solution, a dilute solution of wetting agents and preservatives. It is formulated to serve as a reagent diluent and a wash solution for the SYNCHRON CX 3 and all of its chemistries. The diluent allows the use of concentrated reagents that exhibit improved open stability over more dilute reagents.

This 510(k) submission (K963539) describes a device, "Sigma Diagnostics CX®3 Wash Concentrate," which is a reagent diluent and wash solution for the SYNCHRON CX 3 analyzer and its associated chemistries.

The provided document does not contain any information regarding clinical studies, performance metrics, acceptance criteria, or ground truth establishment for a diagnostic device. Instead, it focuses on demonstrating substantial equivalency to an existing product: "Beckman Wash Concentrate Solution Kit, Part No. 443335."

Therefore, I cannot provide the requested information in a table or structured format as the submission does not include the type of data or studies you've asked about (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance).

The core of this 510(k) is based on the premise that if the new wash concentrate is chemically and functionally equivalent to a legally marketed predicate device, it can be considered safe and effective without extensive new clinical performance studies.

In summary, for K963539:

• Acceptance Criteria & Reported Performance: Not applicable, as no performance metrics or acceptance criteria for a diagnostic output are discussed. The "performance" is implicitly tied to its function as a wash/diluent and its substantial equivalency to the predicate.
• Sample Size (Test Set) & Data Provenance: Not applicable. No clinical test set involving patient data is described.
• Number of Experts & Qualifications: Not applicable. No experts were used to establish ground truth for a diagnostic outcome.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable. The device is a consumable reagent, not an algorithm with standalone performance.
• Type of Ground Truth: Not applicable for diagnostic performance. The "ground truth" for this product would relate to its chemical composition, physical properties, and effectiveness in cleaning/diluting compared to the predicate, likely demonstrated through laboratory-based analytical testing, not clinical outcomes or expert consensus on a diagnosis.
• Sample Size (Training Set): Not applicable. No training set for an algorithm is mentioned.
• How Ground Truth for Training Set Was Established: Not applicable.

The document's statement: "The safety and effectiveness of Sigma Diagnostics Wash Concentrate, Procedure Number W0129, are demonstrated by its substantial equivalency to Beckman Wash Concentrate Solution Kit, Part No. 443335," is the complete "study" rationale provided in this summary. It relies on the predicate device's established safety and effectiveness. Without the full submission, it's impossible to know what analytical data (e.g., chemical analysis, detergent efficacy, impact on assay results) might have been provided to support the claim of substantial equivalency.

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