510(k) Report

510(k) · Cleared

Cleared

Mission Controls

K033063510(k) TraditionalCleared Dec 12, 200374-day reviewClass I21 CFR 862.1660

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

Diamond Diagnostics, Inc. · JJS Controls For Blood-Gases, (Assayed And Unassayed)

Cleared on Dec 12, 2003 as substantially equivalent to K950902 (Alko Diagnostic Corp., 1995) after a 74-day review. Its family tree reaches back 1 generation to 1995.

Decided
Dec 12, 2003
Review
74 days
Class
Class I
Product code
JJS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K950902 (1995). No later device cites it as a predicate yet.

K950902 · Alko Tonometered Saline Control · Alko Diagnostic Corp. · 199519961998200020022004
K950902 · Alko Tonometered Saline Control · Alko Diagnostic Corp. · 19950
  1. Root · 1 generation backK950902 Alko Tonometered Saline ControlAlko Diagnostic Corp. · 1995
  2. This deviceK033063 Mission ControlsDiamond Diagnostics, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950902Alko Tonometered Saline ControlAlko Diagnostic Corp.1995—
0 (this device)K033063Mission ControlsDiamond Diagnostics, Inc.2003—
FIG. 1 — Lineage of K033063, 1995–2003Source: 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 JJS? 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? (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
*K950902Alko Tonometered Saline Control
Summary page 1
…trol I DD-92002 Mission Control Level 2 A700-002 ALKtOnrol 2 DD-92003 Mission Control Level 3 A700-003 ALKOntrol 3 K950902 03-30-1995 DD-92123 Mission Control Level 1, 2, 3 A700-123 ALKOntrol TriLevel DD-92004 Mission Cont…
Alko Diagnostic Corp.1995—

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?

  • Its one ancestor has no recall.

How does its category compare?

All JJS devices

JJS Controls For Blood-Gases, (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJS

1in 2016

2013: 22015: 12016: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJS

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

Recalls per year · JJS

No recall names JJS since 2007.

Adverse event reports per year · JJS

1in 2018

2017: 12018: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code JJS, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20132—00
20140—00
20151—00
20161—00
20170—01
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level. Mission Controls are intended for six systems: AVL Scientific: 990, 995; 982,983,985; 984, 987; 9110,9140; 9180, 9181 Ciba-Corning/Bayer: 248; 278; 288; 614,644; 654; 800 series IL: BG3; 1610,1620 NOVA: Stat Profile 1-5 Radiometer: ABL 300, 330; ABL, 50, 500, 520; BL…

Read the full statement (146 words)

There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level.

Mission Controls are intended for six systems:

AVL Scientific: 990, 995; 982,983,985; 984, 987; 9110,9140; 9180, 9181

Ciba-Corning/Bayer: 248; 278; 288; 614,644; 654; 800 series

IL: BG3; 1610,1620

NOVA: Stat Profile 1-5

Radiometer: ABL 300, 330; ABL, 50, 500, 520; BL 600, 610, 1620; EML-10

Medica, Shappare'li, Medarmin

The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas - (pH, pCO2, pO2), and Electrolyte - (Na, K, Cl, Ca, Li, TCO2) Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.

The products encompassed are to be handled using normal laboratory precautions.

Indications for use as stated in the FDA summary.

More from Diamond Diagnostics, Inc.

26 FDA decisions under this applicant name. See the company

  • K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020
  • K133751Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsDiamond Diagnostics, Inc. · 2014
  • K124009Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level…Diamond Diagnostics, Inc. · 2013
  • K121027Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc. · 2012
  • K121040Smartlyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2012

Recent decisions in JJS

The JJS category page

  • K152553CueSee HypoxicEurotrol B.V. · 2016
  • K150226Hematocrit and Metabolite QUALICHECKRadiometer Medical Aps · 2015
  • K130415High Metabolite QualicheckRadiometer Medical Aps · 2013
  • K130236Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3Radiometer Medical Aps · 2013
  • K022525Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3, Model 507, 508, 509Bio-Rad · 2002

https://510kreport.com/device/K033063 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033063: Mission Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033063

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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