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Clinical laboratories performing chemistry assays may use huve mentioned controls routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls (Levels 1 and 2) are used as an adjunct to primary control procedure recommended by the manufacturer of reagents and instrument used for the measurement; (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory quality control goals; (c ) above mentioned controls are validated for use with the specific clinical chemistry test system used by the laboratory.

QUIKCHECK Unassayed Chemistry Control Levels 1 and 2

This document is a 510(k) premarket notification response from the FDA for a chemistry control device. It does not contain information about studies proving the device meets acceptance criteria as this is typically found in a Premarket Approval (PMA) application or a more detailed 510(k) submission document. The provided text is a notification that the device has been found substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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