; (B) modifying an in vitro clinical test, including modifying the indications for use of the in vitro clinical test, or modifying an article to be an in vitro clinical test; or (C) establishing a test system as described or included in a test protocol developed by another entity unless such test protocol is listed as an in vitro clinical test in the comprehensive test information system established under section 587T by that other entity. (7) Developer The term developer means a person who engages in development as described in paragraph (6), except the term does not include a laboratory that— (A) is certified by the Secretary under section 353 of the Public Health Service Act; and (B) assembles for use solely within that laboratory, without otherwise developing, an in vitro clinical test appropriately listed in the comprehensive test information system established under section 587T by a different person. (8) First-of-a-kind The term first-of-a-kind , with respect to an in vitro clinical test, means that such test has any novel combination of the elements specified in paragraph (10) that differs from in vitro clinical tests that already are legally available in the United States, except for such tests offered under section 587C(a)(3), 587C(a)(4), or 587G. (9) High-risk The term high-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that an undetected inaccurate result from such test, or such category of tests, when used as intended— (A) (i) is reasonably likely to result in serious or irreversible harm or death to a patient or patients, or would otherwise cause serious harm to the public health; or (ii) is reasonably likely to result in the absence, significant delay, or discontinuation of life-supporting or life-sustaining medical treatment