510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Architect CA 19-9XR Assay

K052000510(k) TraditionalCleared Oct 25, 200592-day reviewClass II21 CFR 866.6010Recalls 1

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

Fujirebio Diagnostics,Inc. · NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Cleared on Oct 25, 2005 as substantially equivalent to K020566 (Fujirebio Diagnostics,Inc., 2002) after a 92-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it. It has been recalled once.

Decided
Oct 25, 2005
Review
92 days
Class
Class II
Product code
NIG
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K020566 (2002). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2020: 1 descendant clearedK020566 · Fujirebio Diagnostics CA 19-9 Ria · Fujirebio Diagnostics,Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K020566 · Fujirebio Diagnostics CA 19-9 Ria · Fujirebio Diagnostics,Inc. · 20020
  1. Root · 1 generation backK020566 Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc. · 2002
  2. This deviceK052000 Architect CA 19-9XR AssayFujirebio Diagnostics,Inc. · 2005
  3. Descendant · cites it directly · 1 of its ownK191973 Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. · 2019
  4. Descendant · 2 generations on · 0 of its ownK200997 Lumipulse G CA19-9-NFujirebio Diagnostics,Inc. · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. · 2019 · cites it directly1descendant
  • K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020566Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc.2002—
0 (this device)K052000Architect CA 19-9XR AssayFujirebio Diagnostics,Inc.2005—
+1K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.2019—
+2K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
FIG. 1 — Lineage of K052000, 2002–2020Source: 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 NIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NIG device

  1. #1 K253528 Atellica IM CA 19-9 IIscore 12.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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
*K020566Fujirebio Diagnostics CA 19-9 Ria
Summary page 3
…(Proposed Device) (Predicate Device) K020566 Device Tye In vitro diagnostic In vitro diagnostic ClaClass II, NIG…
Fujirebio Diagnostics,Inc.2002—

Also cleared against K020566: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.20191

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

Recalls of this device

DateClassRecallRoot causeReason
May 30, 2012Class IIZ-1904-2012Nonconforming Material/ComponentThe six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K191973 (Fujirebio Dianostics, Inc., 2019) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K020566.

How does its category compare?

All NIG devices

NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NIG

1in 2023

2011: 12019: 12020: 12023: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NIG

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

Recalls per year · NIG

2in 2016

2010: 12011: 12012: 12016: 2
2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · NIG

98in 2025

2007: 62008: 92009: 112010: 122011: 82012: 1,7852013: 1822014: 1172015: 292016: 692017: 982018: 582019: 1352020: 932021: 692022: 832023: 1292024: 1212025: 98
2007high 1,785 (2012) · low 6 (2007)2025

MAUDE reports naming product code NIG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—09
20090—011
20100—112
20111—18
20120—11,785
20130—0182
20140—0117
20150—029
20160—269
20170—098
20180—058
20191—0135
20201—093
20210—069
20220—083
20231—0129
20240—0121
20250—098
20261—0—

What is it indicated for?

The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. Patients known to be genotypically negative for the Lewis blood group antigen will be unable to…

Read the full statement (218 words)

The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.

The ARCHITECT CA 19-9xR Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma. Refer to the ARCHITECT CA 19-9xR reagent package insert for additional information.

The ARCHITECT CA 19-9xR Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative measurement of 1116-NS-19-9 reactive determinants in human serum or plasma. Refer to the ARCHITECT CA 19-9xR reagent package insert for additional information.

Indications for use as stated in the FDA summary.

Also cleared against K020566

4 other devices cite the same predicate.

  • K052889Vitros CA 19-9Fujirebio Diagnostics,Inc. · 2005
  • K050231Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 CalsetRoche Diagnostics Corp. · 20051 recall
  • K033038GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688Beckman Coulter, Inc. · 20032 recalls
  • K031393Bayer Advia Centaur CA 19-9 AssayBayer Healthcare, LLC · 20038 recalls

More from Fujirebio Diagnostics,Inc.

45 FDA decisions under this applicant name. See the company

  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20257 recalls
  • DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
  • K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020
  • K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020

Recent decisions in NIG

The NIG category page

  • K253528Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc. · 2026
  • K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical Diagnostics · 2023
  • K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc. · 2020
  • K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. · 2019
  • K100375Dimension Vista Loci CA 19-9 Flex Reagent Cartridge, and Dimension LOCI7 Calibrator with Model (S) K6457…Siemens Healthcare Diagnostics, Inc. · 2011

https://510kreport.com/device/K052000 · printed Nov 3, 2026

Cite this page

510(k) Report. “K052000: Architect CA 19-9XR Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052000

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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