JQP Code - Wireless Data Transmission 510k only

S

Silvertabb

#1
Is there a cleared 510k for JQP Code for wireless transmission data that is intended to be used by health professionals only (not available to general public)? It would be great if you identify a device that filed a 510k to just add the wireless option to an existing device.

thanks
 
Elsmar Forum Sponsor
S

singber

#2
Can you provide more information about what type of data this device would be transmitting? This would help confirm that it really fits in the JQP product code.
 
S

singber

#4
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.
 
S

Silvertabb

#5
To me graphing and plotting data is data processing. If your software include the option to plot readings, would this still be covered under the "data processing" portion of the intended use statement of JQP?
 

Michael Malis

Quite Involved in Discussions
#6
Hi Silvertabb,

I am not sure, but you maybe describing patient monitoring software (check 870.2300) or see example in K100133. Also K010828 and K093824 may be of help.

Regards,
Mike
 
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