(a) Identification. A muscular dystrophy newborn screening test is an in vitro diagnostic device intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include a clinical validation study that includes the following:

(i) Results that demonstrate that the analyte being measured identifies a population of newborns who should be subject to follow up diagnostic testing for the condition being screened.

(ii) Predictive value of the device demonstrated using either well characterized prospectively or retrospectively obtained clinical specimens from the intended use population.

(iii) Testing performed by device users who are representative of the types of operators intended to use the test.

(iv) A design that assesses the effects of sample collection and processing steps on test performance.

(v) Tested confirmed positive specimens must have associated diagnostic outcome information based on confirmatory diagnostic methods, or clinically meaningful information regarding the status of the subject must be obtained.

(vi) Data, provided or referenced, generated in samples from the intended use population, that demonstrates the upper reference interval(s), including sufficient samples to calculate the 97.5th and 99.5th percentile information, for the analyte or analytes measured by the device.

(2) The labeling required under § 809.10(b) of this chapter must include:

(i) A warning which states that test results are not intended to diagnose muscular dystrophies.

(ii) A warning which states that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, and clinical evaluation as appropriate.

(iii) Detailed information on device performance, including the false positive screen rate and the false negative screen rate observed in the clinical study, and any limitations to the data generated in the clinical study (e.g., necessity for testing at a specific age).

(iv) Information on device performance in relevant subgroups (e.g., age of newborn at time of sample collection, birth weight, sex, gestational age) observed in the clinical study.