510(k) Report

510(k) · Cleared

Cleared

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

K101392510(k) TraditionalCleared Feb 4, 2011262-day reviewClass II21 CFR 862.1315

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Astoria-Pacific, Inc. · KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

Cleared on Feb 4, 2011 as substantially equivalent to K883020 (Alpkem Corp., 1988) and 1 other predicate after a 262-day review. Its family tree reaches back 1 generation to 1985.

Decided
Feb 4, 2011
Review
262 days
Class
Class II
Product code
KQP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K851542 (1985). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1988: 1 other ancestorK851542 · Rfa-300 Rapid Flow Analyzer W/Computer · Alpkem Corp. · 1985198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K851542 · Rfa-300 Rapid Flow Analyzer W/Computer · Alpkem Corp. · 19850
  1. Root · 1 generation backK851542 Rfa-300 Rapid Flow Analyzer W/ComputerAlpkem Corp. · 1985
  2. This deviceK101392 Neopac Software, 3007 Digital Photometer/Fluorometer Model NA, 307…Astoria-Pacific, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851542Rfa-300 Rapid Flow Analyzer W/ComputerAlpkem Corp.1985—
0 (this device)K101392Neopac Software, 3007 Digital Photometer/Fluorometer Model NA, 307 and 350DAstoria-Pacific, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
FIG. 1 — Lineage of K101392, 1985–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K883020Rfa-300 Rapid Flow Analyzer W/Computer
Summary page 1
…substantial equivalence is claimed The proposed devices are new components of Astoria-Pacific's FDA-cleared SPOTCHECK Analyzer system with associated 510(k) numbers k883020 and k85 1542. Page 1 of 10 cAstoria-Pacifi&- INT E…
Alpkem Corp.1988—
*K851542Rfa-300 Rapid Flow Analyzer W/Computer
Summary page 1
…equivalence is claimed The proposed devices are new components of Astoria-Pacific's FDA-cleared SPOTCHECK Analyzer system with associated 510(k) numbers k883020 and k85 1542. Page 1 of 10 cAstoria-Pacifi&- INT E RN A TI10NA…
Alpkem Corp.1985—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.

How does its category compare?

All KQP devices

KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KQP

2in 2011

2010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KQP

Too few KQP 510(k)s in any year since 2007 to give a median.

Recalls per year · KQP

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KQP

No MAUDE report names KQP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20112—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—1—

What is it indicated for?

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…

Read the full statement (421 words)

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.

Indications for use as stated in the FDA summary.

More from Astoria-Pacific, Inc.

9 FDA decisions under this applicant name. See the company

  • K121101Spotcheck Neonatal Total Galactose Microplate Reagent KitAstoria-Pacific, Inc. · 2013
  • K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011
  • K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009
  • K080294Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitAstoria-Pacific, Inc. · 2008
  • K010844Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13KAstoria-Pacific, Inc. · 2001

Recent decisions in KQP

The KQP category page

  • K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011
  • K100101GSP Neonatalgalt Kit, Model 3303-001UPerkinelmer, Inc. · 20101 recall
  • K993536Bio-Rad Coda Neonatal Galt AssayBio-Rad · 1999
  • K990827Microplate Neonatal Galt AssayBio-Rad · 1999
  • K970277Uridyltransferase Kit, 50 Hour (80-4000-13K)Astoria-Pacific, Inc. · 19971 recall

https://510kreport.com/device/K101392 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101392: Neopac Software, 3007 Digital Photometer/Fluorometer Model NA, 307 and 350D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101392

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026