# K101392: Neopac Software, 3007 Digital Photometer/Fluorometer Model NA, 307 and 350D

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Feb 4, 2011 after 262 days
- Product code: KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase)
- Device class: 2
- Regulation: 21 CFR 862.1315
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851542 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883020: Rfa-300 Rapid Flow Analyzer W/Computer, Alpkem Corp. (1988) Summary page 1.
- K851542: Rfa-300 Rapid Flow Analyzer W/Computer, Alpkem Corp. (1985) Summary page 1.

## Indications for use
The SPOTCHECK Flow system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are: * Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK Uridyltransferase 50 Hour Reagent Kit * Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit * Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit * Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit * Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes. The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are: * Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK Uridyltransferase 50 Hour Reagent Kit * Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit * Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit * Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit * Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit * Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes. The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn error in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assay are: Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes. The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are: * Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK Uridyltransferase 50 Hour Reagent Kit * Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit * Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit * Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit * Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes.

Source page: https://510kreport.com/device/K101392
Methodology: https://510kreport.com/methodology