Most 510K records have the value "Summary" stored in the Summary field.
There is no such thing as the "Summary" field.
A statement or summary can be provided per 21 CFR 807.3(n) and (o). A
510(k) summary, submitted under section 513(i) of the act, of the
safety and effectiveness information contained in a premarket
notification submission upon which a determination of substantial
equivalence can be based. Safety and effectiveness information refers
to safety and effectiveness data and information supporting a finding
of substantial equivalence, including all adverse safety and
effectiveness. The 510(k) Statement is a statement, made under section
513(i) of the act, asserting that all information in a premarket
notification submission regarding safety and effectiveness will be
made available within 30 days of request by any person if the device
described in the premarket notification submission is determined to be
Thus, in your example, "Summary" is a title, and "Liquichek Cardiac Troponins Control" is a subtitle.
API response does not contain the value of this subtitle.
The value of the
statement_or_summary field is a type of document:
- "statement" (68000 items),
- "summary" (25000 items),
- empty record (55 000 items).
I think, in many cases, the value of subtitle should be similar to the value of the
Also, if you don’t specify a field to search, the API will search in every field.