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U.S. Department of Health and Human Services

Product Classification
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Device ldt, unmet need within an integrated healthcare system
Definition Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Physical State In Vitro diagnostic device
Technical Method In Vitro diagnostic device
Target Area In Vitro diagnostic device
Review Panel Clinical Chemistry
Product CodeSCF
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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