510(k) Report

510(k) · Cleared

Cleared

Validate Chem 1 Calibration Verification Test Set, Model 10001

K012117510(k) TraditionalCleared Aug 20, 200145-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. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Aug 20, 2001 as substantially equivalent to K870252 (Casco Standards, 1987) and 3 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.

Decided
Aug 20, 2001
Review
45 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K870252 (1987). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor2005: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant clearedK870252 · Document (TM) Multi-Analyte Linearity Test Set · Casco Standards · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K870252 · Document (TM) Multi-Analyte Linearity Test Set · Casco Standards · 19870
  1. Root · 1 generation backK870252 Document (TM) Multi-Analyte Linearity Test SetCasco Standards · 1987
  2. This deviceK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
  3. Descendant · cites it directly · 3 of its ownK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
  4. Descendant · 2 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
  5. Descendant · 2 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
  6. Descendant · 3 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
  7. Descendant · cites it directly · 0 of its ownK050504 Validate Urine Chemistry Calibration Verification Test SetsMaine Standards Co. · 2005

Most influential descendants

Showing 5 of 5 · See all
  • K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002 · cites it directly3descendants
  • K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 2 generations on1descendant
  • K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 2 generations on0descendants
  • K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 3 generations on0descendants
  • K050504Validate Urine Chemistry Calibration Verification Test SetsMaine Standards Co. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K870252Document (TM) Multi-Analyte Linearity Test SetCasco Standards1987—
0 (this device)K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co.2001—
+1K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc.2002—
+2K090405Lipidpro SystemInfopia Co, Ltd.2009—
+2K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor2017—
+3K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional…Infopia Co, Ltd.2013—
+1K050504Validate Urine Chemistry Calibration Verification Test SetsMaine Standards Co.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200910
201310
201710
FIG. 1 — Lineage of K012117, 1987–2017Source: 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 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? (5)

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
*K870252Document (TM) Multi-Analyte Linearity Test Set
Summary page 1
…ration Verification Test Set Common Name: Calibration Verification Classification Name: Calibrator, Multi-Analyte Predicate Devices: 1. DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO NERL Diagnostics. 2. DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics. ' 3.…
Casco Standards1987—
*K881773Document (TM) Direct Ise Linearity Test Set
Summary page 1
…Name: Calibrator, Multi-Analyte Predicate Devices: 1. DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO NERL Diagnostics. 2. DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics. ' 3. DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL…
Casco Standards1988—
*K893142Document (TM) Iron, Magnes, Trigly Linear Test Set
Summary page 1
…factured by CASCO NERL Diagnostics. 2. DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics. ' 3. DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL Diagnostics. 4. DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by CASCO NERL Diagnostics.…
Casco Standards1989—
*K962629Document Ammonia, Ethanol, Lactate Calibrator
Summary page 1
…red by CASCO NERL Diagnostics. ' 3. DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL Diagnostics. 4. DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by CASCO NERL Diagnostics. 5. Precitrol Ethyl Alcohol/Ammonia/Lactate Control, Roche Diagnostics. Device descript…
Casco Standards1996—
*—Precitrol Ethyl Alcohol/Ammonia/Lactate Control
Named without a submission number
—

Also cleared against K870252: 2 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc.20023
K050504Validate Urine Chemistry Calibration Verification Test SetsMaine Standards Co.20050

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K022401 (Polymer Technology Systems, Inc., 2002) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K870252.

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—

What is it indicated for?

The VALIDATE Chem 1 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the fcllowing analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K870252

2 other devices cite the same predicate.

  • K013265Validate Chem 7 Calibration Verification Test Set, Model 10007Maine Standards Co. · 2001
  • K012118Validate Chem 2 Calibration Verification Test Set, Model 10002Maine Standards Co. · 2001

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 JJY

The JJY category page

  • K162530Multichem IA PlusTechno-Path Manufacturing · 2017
  • K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories · 2015

https://510kreport.com/device/K012117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012117: Validate Chem 1 Calibration Verification Test Set, Model 10001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012117

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026