510(k) Report

510(k) · Cleared

Cleared

Stat Profile Critical Care Xpress (CCX), Model 1+

K061830510(k) TraditionalCleared Nov 1, 2006126-day reviewClass II21 CFR 862.1110

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

Nova Biomedical Corp. · CIG Diazo Colorimetry, Bilirubin

Cleared on Nov 1, 2006 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.

Decided
Nov 1, 2006
Review
126 days
Class
Class II
Product code
CIG
Recalls
None
Predicates
0

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2020: 4 descendants cleared2019: 2 descendants cleared2018: 4 descendants cleared2023: 1 descendant cleared2014: 2 descendants cleared2015: 2 descendants cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK061830 Stat Profile Critical Care Xpress (CCX), Model 1+Nova Biomedical Corp. · 2006
  2. Descendant · cites it directly · 16 of its ownK110648 Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation · 2011
  3. Descendant · 2 generations on · 3 of its ownK131703 Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation · 2014 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK180428 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
  5. Descendant · 3 generations on · 1 of its ownK200403 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK180340 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011: 12014: 22015: 22018: 42019: 22020: 42023: 12026: 1
2011high 4 (2018) · low 0 (2012)2026

Most influential descendants

Showing 5 of 17 · See all
  • K110648Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation · 2011 · cites it directly16descendants
  • K131703Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation · 2014 · 2 generations on3descendants
  • K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018 · 2 generations on2descendants
  • K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020 · 3 generations on1descendant
  • K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061830Stat Profile Critical Care Xpress (CCX), Model 1+Nova Biomedical Corp.2006—
+1K110648Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation2011—
+2K131703Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation20141
+2K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2018—
+3K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20202
+2K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201420
201520
201840
201920
202040
202310
202610
FIG. 1 — Lineage of K061830, 2006–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CIG? 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 CIG device

  1. #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K110648Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation201116

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?

  • Of its descendants, K110648 (Nova Biomedical Corporation, 2011) has gone furthest, with 16 descendants of its own.

How does its category compare?

All CIG devices

CIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIG

2in 2023

2007: 12008: 32009: 22010: 12011: 22013: 52015: 12017: 12019: 12022: 12023: 22026 (partial year): 1
2007high 5 (2013) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIG

64in 2013

2008: 199 days median2013: 64 days median
2007high 199 (2008) · low 64 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CIG

1in 2019

2009: 32013: 32019: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CIG

52in 2025

2007: 22008: 82009: 32010: 62011: 382012: 142013: 82014: 32015: 72016: 42017: 112018: 232019: 252020: 312021: 222022: 262023: 342024: 392025: 52
2007high 52 (2025) · low 2 (2007)2025

MAUDE reports naming product code CIG, 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
20071—02
2008319908
20092—33
20101—06
20112—038
20120—014
201356438
20140—03
20151—07
20160—04
20171—011
20180—023
20191—125
20200—031
20210—022
20221—026
20232—034
20240—039
20250—052
20261—0—

What is it indicated for?

The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, P02, S02%, Hematocrit (Hct), total Hemoglobin (tub), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (Met-b), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (O2Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-…

Read the full statement (169 words)

The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, P02, S02%, Hematocrit (Hct), total Hemoglobin (tub), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (Met-b), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (O2Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer.

Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.

Indications for use as stated in the FDA 510(k) statement.

More from Nova Biomedical Corp.

89 FDA decisions under this applicant name. See the company

  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011
  • K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp. · 2010
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 201010 Class I recalls
  • K070960Nova Statstrip Xpress Glucose Hospital Meter SystemNova Biomedical Corp. · 20071 recall
  • K070255Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp. · 2007

Recent decisions in CIG

The CIG category page

  • K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026
  • K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K223324Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
  • K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc. · 20193 recalls

https://510kreport.com/device/K061830 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061830: Stat Profile Critical Care Xpress (CCX), Model 1+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061830

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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