510(k) Report

510(k) · Cleared

Cleared

Bioscanner Triglycerides Test Strips

K991894510(k) TraditionalCleared May 24, 2000356-day reviewClass I21 CFR 862.1705

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

Polymer Technology Systems, Inc. · JGY Colorimetric Method, Triglycerides

Cleared on May 24, 2000 as substantially equivalent to K870012 (Sigma Diagnostics, Inc., 1987) after a 356-day review. Its family tree reaches back 1 generation to 1987. 12 later devices descend from it.

Decided
May 24, 2000
Review
356 days
Class
Class I
Product code
JGY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K870012 (1987). 12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2007: 1 descendant cleared2002: 1 descendant cleared2014: 1 descendant cleared2015: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared2016: 1 descendant clearedK870012 · Triglyceride (Gpo-Trinder) Reagent · Sigma Diagnostics, Inc. · 19871990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 5 descendants5 generations forward: 1 descendant K870012 · Triglyceride (Gpo-Trinder) Reagent · Sigma Diagnostics, Inc. · 19870+5
  1. Root · 1 generation backK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
  2. This deviceK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
  3. Descendant · cites it directly · 9 of its ownK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK022898 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 7 of its ownK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
  6. Descendant · 3 generations on · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
  7. Descendant · 4 generations on · 1 of its ownK163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro…ACON Laboratories, Inc. · 2017

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2001: 22002: 12007: 12014: 12015: 22016: 12017: 12018: 12022: 2
2001high 2 (2001) · low 0 (2003)2026

Most influential descendants

Showing 5 of 12 · See all
  • K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · cites it directly9descendants
  • K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · 2 generations on7descendants
  • K014099Bioscanner PlusPolymer Technology Systems, Inc. · 2001 · 2 generations on7descendants
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · 3 generations on6descendants
  • K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc. · 2017 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K870012Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc.1987—
0 (this device)K991894Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc.2000—
+1K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.20011
+2K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.20021
+2K014099Bioscanner PlusPolymer Technology Systems, Inc.2001—
+3K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.20154
+4K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200710
201410
201520
201610
201710
201810
202220
FIG. 1 — Lineage of K991894, 1987–2022Source: 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 JGY? 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
*K870012Triglyceride (Gpo-Trinder) Reagent
Summary page 1
…riglycerides Test Strips are substantially equivalent to the predicate device noted below. Name: Triglyceride (GPO-Trinder) Reagent Device Company: Sigma 510(k) Number: K870012 Similarities and Differences (Predicate and BioScanner Triglycerides) Similarities Both systems determine total…
Sigma Diagnostics, Inc.1987—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.20019
K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc.20071

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.
  • Of its descendants, K013173 (Polymer Technology Systems, Inc., 2001) has gone furthest, with 9 descendants of its own.

How does its category compare?

All JGY devices

JGY Colorimetric Method, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGY

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGY

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

Recalls per year · JGY

No recall names JGY since 2007.

Adverse event reports per year · JGY

1in 2021

2008: 22011: 12021: 1
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code JGY, 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—02
20090—00
20100—00
20110—01
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.

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

More from Polymer Technology Systems, Inc.

27 FDA decisions under this applicant name. See the company

  • K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test…Polymer Technology Systems, Inc. · 20162 recalls
  • K151530CardioChek Plus Test SystemPolymer Technology Systems, Inc. · 2015
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 20154 recalls
  • K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test…Polymer Technology Systems, Inc. · 2014
  • K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 20071 recall

Recent decisions in JGY

The JGY category page

  • K120664Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc. · 2012
  • K023639Piccolo Triglycerides Test SystemAbaxis, Inc. · 2003
  • K000586Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
  • K971005TriglyceridesDerma Media Lab., Inc. · 1997
  • K954187Triglycerides ReagentSchiapparelli Biosystems, Inc. · 1995

https://510kreport.com/device/K991894 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991894: Bioscanner Triglycerides Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991894

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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