Device |
modified version of another manufacturer’s fda-authorized test within scope described in preamble to ldt final rule |
Definition |
When a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting CLIA’s regulatory requirements to perform high complexity testing modifies another manufacturer’s 510(k) cleared or De Novo authorized test, and in compliance as described in section V.C.3 of the preamble to the LDT Final Rule, in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification as described in sections V.C.4 and V.C.5 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 Code | SCG |
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 |