510(k) Report

510(k) · Cleared

Cleared

Document Serum Multianalyte Calibration Verification Test Set

K950469510(k) TraditionalCleared Apr 11, 199567-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

Casco Standards · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Apr 11, 1995 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.

Decided
Apr 11, 1995
Review
67 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
0

48 later devices descend from it, 18 citing it directly.

Descendants, by year cleared 1999: 7 descendants cleared1998: 11 descendants cleared2002: 1 descendant cleared2004: 2 descendants cleared2006: 1 descendant cleared2009: 3 descendants cleared2010: 1 descendant cleared2011: 3 descendants cleared2013: 2 descendants cleared2014: 10 descendants cleared2017: 1 descendant cleared2015: 5 descendants cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
  2. Descendant · cites it directly · 29 of its ownK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
  3. Descendant · 2 generations on · 26 of its ownK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
  4. Descendant · 3 generations on · 18 of its ownK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
  5. Descendant · 4 generations on · 14 of its ownK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
  6. Descendant · 5 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

1998: 111999: 72002: 12004: 22006: 12009: 32010: 12011: 32013: 22014: 102015: 52017: 12020: 1
1998high 11 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 48 · See all
  • K992034Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999 · cites it directly29descendants
  • K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co. · 2006 · 2 generations on26descendants
  • K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010 · 3 generations on18descendants
  • K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011 · 4 generations on14descendants
  • K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 5 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950469Document Serum Multianalyte Calibration Verification Test SetCasco Standards1995—
+1K992034Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine)1999—
+2K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co.2006—
+3K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics2010—
+4K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics2011—
+5K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…Siemens Healthcare Diagnostics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
1998110
199970
200210
200420
200610
200930
201010
201130
201320
2014100
201550
201710
202010
FIG. 1 — Lineage of K950469, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJY? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K992034Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine)199929
K990393Architect Progesterone Mastercheck Model #6C26-05Bio-Rad19991
K023352Validate Chem 9 Calibration Verification Test Set, Model 109Maine Standards Co.20020
K990608Architect Cea Mastercheck, Model 6CO2-05Bio-Rad19990
K984625Architect Folate Masterchek, Model # 6C12-05Bio-Rad19990
K984604Architect Estradiol Masterchek, Model # 6C22-05Bio-Rad19990
K984626Architect B12 Masterchek, Model # 6C09-O5Bio-Rad19990
K984319Architect Free T3 Mastercheck, Model Number 6C48-05Bio-Rad19980
K984327Architect Total T3 Mastercheck, Model Number 6C51-05Bio-Rad19980
K984325Architect Ferritin Mastercheck, Model Number 6C11-05Bio-Rad19980

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, K992034 (Casco-Nerl Diagnostics Corporation (Maine), 1999) has gone furthest, with 29 descendants of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—

More from Casco Standards

38 FDA decisions under this applicant name. See the company

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  • K972904Document Molecular Pathology Chlamydia Trachomatis ControlCasco Standards · 1998
  • K962629Document Ammonia, Ethanol, Lactate CalibratorCasco Standards · 1996
  • K961750Document Cardiac Assayed ControlCasco Standards · 1996
  • K962630Document Ammonia, Ethanol, Lactate Assayed ControlCasco Standards · 1996

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The JJY category page

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https://510kreport.com/device/K950469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950469: Document Serum Multianalyte Calibration Verification Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950469

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026