If it truly fits the definition of the JQP code, then it doesn't seem like a 510(k) would be required, although you would have to follow all design control regulations:
PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C--Clinical Laboratory Instruments
Sec. 862.2100 Calculator/data processing module for clinical use.
(a)Identification. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9.
Sec. 862.2100 Calculator/data processing module for clinical use. (a)Identification. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9.
Sec. 862.2100 Calculator/data processing module for clinical use. (a)Identification. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9.