510(k) Report

510(k) · Cleared

Cleared

Validate Thyroid Calibration Verification / Linearity Test Set, Model 901

K062501510(k) TraditionalCleared Sep 29, 200635-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

Maine Standards Co. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Sep 29, 2006 as substantially equivalent to K992034 (Casco-Nerl Diagnostics Corporation (Maine), 1999) after a 35-day review. Its family tree reaches back 2 generations to 1995. 26 later devices descend from it.

Decided
Sep 29, 2006
Review
35 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K950469 (1995). 26 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2010: 1 descendant cleared2011: 3 descendants cleared2013: 2 descendants cleared2014: 10 descendants cleared2017: 1 descendant cleared2015: 5 descendants cleared2020: 1 descendant clearedK950469 · Document Serum Multianalyte Calibration Verification Test Set · Casco Standards · 1995K992034 · Document Thyroid Cal*Ver · Casco-Nerl Diagnostics Corporation (Maine) · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 7 descendants5 generations forward: 3 descendants K992034 · Document Thyroid Cal*Ver · Casco-Nerl Diagnostics Corporation (Maine) · 1999K950469 · Document Serum Multianalyte Calibration Verification Test Set · Casco Standards · 19950+5
  1. Root · 2 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
  2. 1 generation backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
  3. This deviceK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
  4. Descendant · cites it directly · 18 of its ownK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
  5. Descendant · 2 generations on · 14 of its ownK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
  6. Descendant · 3 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
  7. Descendant · 4 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
  8. Descendant · 2 generations on · 5 of its ownK133124 Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc. · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2009: 32010: 12011: 32013: 22014: 102015: 52017: 12020: 1
2009high 10 (2014) · low 0 (2012)2026

Most influential descendants

Showing 5 of 26 · See all
  • K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010 · cites it directly18descendants
  • K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011 · 2 generations on14descendants
  • K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 3 generations on13descendants
  • K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 4 generations on7descendants
  • K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K950469Document Serum Multianalyte Calibration Verification Test SetCasco Standards1995—
−1K992034Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine)1999—
0 (this device)K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co.2006—
+1K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics2010—
+2K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics2011—
+3K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…Siemens Healthcare Diagnostics, Inc.2013—
+4K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration…Siemens Healthcare Diagnostics, Inc.2014—
+2K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201010
201130
201320
2014100
201550
201710
202010
FIG. 1 — Lineage of K062501, 1995–2020Source: 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 JJX? 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
*K992034Document Thyroid Cal*Ver
Summary page 1
…: 21 CIFR 862.1660 Product Code: JJY Regulatory Class: Class I Predicate Device: DOCUMENT Thyroid CAL*VER (K992034), Microgenics Corp, Fremont, CA Device description: VALIDATE Thyroid Calibration Verification Test Sets are human serum based ca…
Casco-Nerl Diagnostics Corporation (Maine)1999—

Also cleared against K992034: 2 other devices →

What descends from it? (26)

See all 26

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics201018
K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc.20113
K092993Advia Centaur Cyclosporine Master Curve MaterialSiemens Healthcare Diagnostics20090
K091123Advia Centaur Dheas Master Curve MaterialsSiemens Healthcare Diagnostics20090
K083891Validate Thyroid Calibration Verification Test Set, Model 901Maine Standards Co.20090

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?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K102904 (Siemens Healthcare Diagnostics, 2010) has gone furthest, with 18 descendants of its own.
  • 2 other devices also cite its predicate K992034.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.

Indications for use as stated in the FDA summary.

Also cleared against K992034

2 other devices cite the same predicate.

  • K041073Document Salicylate Cal VerMicrogenics Corp. · 2004
  • K993014Modification to Document Thyroid Cal.VerCasco-Nerl Diagnostics Corporation (Maine) · 1999

More from Maine Standards Co.

23 FDA decisions under this applicant name. See the company

  • K123127Validate Psa Calibration Verification/ Linearity Test Kit Model 406Maine Standards Co. · 2013
  • K113524Validate Vit D Calibration Verification/ Linearity Test KitMaine Standards Co. · 2012
  • K103271MSC Lipid ControlMaine Standards Co. · 2011
  • K091225Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetMaine Standards Co. · 2009
  • K090475Validate CM2 Calibration Verification / Linearity Test Set, Model 402Maine Standards Co. · 2009

Recent decisions in JJX

The JJX category page

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  • K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K062501 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062501

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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