510(k) Report

510(k) · Cleared

Cleared

Poly-Chem Glucose

K020852510(k) TraditionalCleared Jul 3, 2002110-day reviewClass II21 CFR 862.1345

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

Polymedco, Inc. · CFR Hexokinase, Glucose

Cleared on Jul 3, 2002 after a 110-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Jul 3, 2002
Review
110 days
Class
Class II
Product code
CFR
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 4 descendants cleared2005: 1 descendant cleared2006: 2 descendants cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK020852 Poly-Chem GlucosePolymedco, Inc. · 2002
  2. Descendant · cites it directly · 7 of its ownK041720 Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK042477 Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
  4. Descendant · 3 generations on · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
  5. Descendant · 4 generations on · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
  6. Descendant · 5 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 42005: 12006: 22013: 1
2004high 4 (2004) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K041720Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly7descendants
  • K042477Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…Ortho-Clinical Diagnostics, Inc. · 2004 · 2 generations on4descendants
  • K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 3 generations on3descendants
  • K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · 4 generations on1descendant
  • K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020852Poly-Chem GlucosePolymedco, Inc.2002—
+1K041720Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Ortho-Clinical Diagnostics, Inc.20041
+2K042477Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator…Ortho-Clinical Diagnostics, Inc.2004—
+3K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance…Ortho-Clinical Diagnostics, Inc.2005—
+4K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator…Ortho-Clinical Diagnostics, Inc.20061
+5K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance…Ortho-Clinical Diagnostics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200440
200510
200620
201310
FIG. 1 — Lineage of K020852, 2002–2013Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CFR device

  1. #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041720Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Ortho-Clinical Diagnostics, Inc.20047

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, K041720 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 7 descendants of its own.

How does its category compare?

All CFR devices

CFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFR

1in 2025

2007: 12008: 52009: 32011: 32012: 42013: 12014: 12016: 22017: 12019: 12022: 12025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CFR

115in 2012

2008: 182 days median2009: 101 days median2011: 316 days median2012: 115 days median
2007high 316 (2011) · low 101 (2009)2026

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

Recalls per year · CFR

1in 2016

2008: 72009: 12012: 12014: 12016: 1
2007high 7 (2008) · low 0 (2007)2026

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

Adverse event reports per year · CFR

16in 2025

2007: 12008: 22009: 72010: 112011: 432012: 492013: 362014: 22015: 32016: 12017: 132018: 82019: 102020: 42021: 52022: 32023: 292024: 152025: 16
2007high 49 (2012) · low 1 (2007)2025

MAUDE reports naming product code CFR, 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
20071—01
2008518272
2009310117
20100—011
20113316043
20124115149
20131—036
20141—12
20150—03
20162—11
20171—013
20180—08
20191—010
20200—04
20210—05
20221—03
20230—029
20240—015
20251—016
20261—0—

What is it indicated for?

The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure

intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer. Glucose measurements are used in the diagnosis and treatment of

carbohydrate metabolism disorders including diabetes mellitus, neonatal

hypoglycemia, and idiopathic hypoglycemia, and of the pancreatic isle cell

carcinoma.

Indications for use as stated in the FDA 510(k) statement.

More from Polymedco, Inc.

19 FDA decisions under this applicant name. See the company

  • K112408Poly-Chem 90 Ise ModulePolymedco, Inc. · 2011
  • K110818Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsPolymedco, Inc. · 2011
  • K111143Poly-Chem 90 Total BilirubinPolymedco, Inc. · 2011
  • K100550Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90 Cholesterol…Polymedco, Inc. · 2010
  • K090703Poly-Chem 90 GlucosePolymedco, Inc. · 2009

Recent decisions in CFR

The CFR category page

  • K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics · 2026
  • K252357Glucose2Abbott Ireland · 2025
  • K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II…Roche Diagnostics · 2022
  • K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics · 20193 recalls
  • K170316Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 20171 recall

https://510kreport.com/device/K020852 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020852: Poly-Chem Glucose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020852

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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