510(k) Report

510(k) · Cleared

Cleared

Document (TM) Direct Ise Linearity Test Set

K881773510(k) TraditionalCleared Jun 10, 198845-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 · JJR Electrolyte Controls (Assayed And Unassayed)

Cleared on Jun 10, 1988 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Jun 10, 1988
Review
45 days
Class
Class I
Product code
JJR
Recalls
None
Predicates
0

8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2002: 2 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK881773 Document (TM) Direct Ise Linearity Test SetCasco Standards · 1988
  2. Descendant · cites it directly · 5 of its ownK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
  3. Descendant · 2 generations on · 3 of its ownK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
  4. Descendant · 3 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
  5. Descendant · 3 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
  6. Descendant · 4 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2001: 22002: 22005: 12009: 12013: 12017: 1
2001high 2 (2001) · low 0 (2003)2026

Most influential descendants

Showing 5 of 8 · See all
  • K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001 · cites it directly5descendants
  • K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002 · 2 generations on3descendants
  • K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 3 generations on1descendant
  • K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 3 generations on0descendants
  • K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881773Document (TM) Direct Ise Linearity Test SetCasco Standards1988—
+1K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co.2001—
+2K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc.2002—
+3K090405Lipidpro SystemInfopia Co, Ltd.2009—
+3K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor2017—
+4K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional…Infopia Co, Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200220
200510
200910
201310
201710
FIG. 1 — Lineage of K881773, 1988–2017Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJR? 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? (8)

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

NumberDeviceApplicantDecidedDescendants
K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co.20015
K020450Validate Chem 8 Calibration Verification Test Set; Model 108Maine Standards Co.20020
K012118Validate Chem 2 Calibration Verification Test Set, Model 10002Maine Standards Co.20010

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, K012117 (Maine Standards Co., 2001) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JJR devices

JJR Electrolyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJR

FDA has decided no JJR device since 2007.

Median 510(k) review, days · JJR

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

Recalls per year · JJR

No recall names JJR since 2007.

Adverse event reports per year · JJR

No MAUDE report names JJR since 2007.

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
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Casco Standards

38 FDA decisions under this applicant name. See the company

  • K981436Document Ammonia/Ethanol/Lactate Calibrator, PN: M-109Casco Standards · 1998
  • K972904Document Molecular Pathology Chlamydia Trachomatis ControlCasco Standards · 1998
  • K962629Document Ammonia, Ethanol, Lactate CalibratorCasco Standards · 1996
  • K962630Document Ammonia, Ethanol, Lactate Assayed ControlCasco Standards · 1996
  • K961750Document Cardiac Assayed ControlCasco Standards · 1996

Recent decisions in JJR

The JJR category page

  • K990971Easylyte Quality Control Kit, Models 2814, 2815, 2816Medica Corp. · 1999
  • K960592Electrolyte StandardsPhoenix Diagnostics, Inc. · 1996
  • K955630Rna Medical Hemat ControlBionostics, Inc. · 1996
  • K951435Aalto Scientific Sweat Chloride Reference MaterialAalto Scientific, Ltd. · 1995
  • K943925Sweat Controls for Cystic Fibrosis TestingQuantimetrix Corp. · 1994

https://510kreport.com/device/K881773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881773: Document (TM) Direct Ise Linearity 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/K881773

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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