510(k) Report

510(k) · Cleared

Cleared

Calcium, Azo Dye Reagent

K040972510(k) TraditionalCleared Dec 27, 2004257-day reviewClass II21 CFR 862.1145

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

Genchem, Inc. · CJY Azo Dye, Calcium

Cleared on Dec 27, 2004 as substantially equivalent to K941764 (Hi Chem, Inc., 1994) after a 257-day review. Its family tree reaches back 1 generation to 1994.

Decided
Dec 27, 2004
Review
257 days
Class
Class II
Product code
CJY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K941764 (1994). No later device cites it as a predicate yet.

K941764 · Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808 · Hi Chem, Inc. · 19941990199520002005
K941764 · Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808 · Hi Chem, Inc. · 19940
  1. Root · 1 generation backK941764 Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808Hi Chem, Inc. · 1994
  2. This deviceK040972 Calcium, Azo Dye ReagentGenchem, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941764Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808Hi Chem, Inc.1994—
0 (this device)K040972Calcium, Azo Dye ReagentGenchem, Inc.2004—
FIG. 1 — Lineage of K040972, 1994–2004Source: 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 CJY? 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 CJY device

  1. #1 K244042 Calcium2score 9.4 · 3 generations · no Class I recall
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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
*K941764Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808
Summary page 1
…hron CX3® System. 5.0 Substantial Equivalence Information: a. Predicate Device Name: HICHEM Calcium Reagent for the CX3 b. Predicate K Number: K941764 c. Comparison with Predicate: The two products have the same intended use, chemical principle, compositio…
Hi Chem, Inc.1994—

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All CJY devices

CJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CJY

1in 2025

2007: 22008: 22009: 12012: 12013: 12015: 12018: 12019: 12025: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CJY

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

Recalls per year · CJY

1in 2022

2013: 42018: 22022: 1
2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CJY

59in 2025

2007: 32008: 42009: 82010: 102011: 92012: 52013: 82014: 52015: 42016: 32017: 262018: 212019: 292020: 332021: 242022: 172023: 292024: 342025: 59
2007high 59 (2025) · low 3 (2007)2025

MAUDE reports naming product code CJY, 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
20072—03
20082—04
20091—08
20100—010
20110—09
20121—05
20131—48
20140—05
20151—04
20160—03
20170—026
20181—221
20191—029
20200—033
20210—024
20220—117
20230—029
20240—034
20251—059
20260—0—

What is it indicated for?

GenChem Calcium Reagent is intended for the quantitative determination of total

calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid

in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

Indications for use as stated in the FDA summary.

More from Genchem, Inc.

8 FDA decisions under this applicant name. See the company

  • K090283Calibrator 1,2, and 3 Models: Gen-CAL1, Gen-CAL2, and Gen-CAL3Genchem, Inc. · 2009
  • K040977Genchem Electrolyte BufferGenchem, Inc. · 2004
  • K040974Glucose Oxidase, GlucoseGenchem, Inc. · 2004
  • K040975Genchem CO2 Acid ReagentGenchem, Inc. · 2004
  • K040973Bun ReagentGenchem, Inc. · 2004

Recent decisions in CJY

The CJY category page

  • K244042Calcium2Abbott Ireland · 2025
  • K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019
  • K182042Randox Calcium (Ca)Randox Laboratories, Ltd. · 20181 recall
  • K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup · 2015
  • K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx…Horiba Abx Sas · 2013

https://510kreport.com/device/K040972 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040972: Calcium, Azo Dye Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040972

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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