510(k) Report

510(k) · Cleared

Cleared

Ilab 600 Clinical Chemistry System

K980757510(k) TraditionalCleared Apr 21, 199853-day reviewClass II21 CFR 862.1170

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

Instrumentation Laboratory CO · CGZ Electrode, Ion-Specific, Chloride

Cleared on Apr 21, 1998 as substantially equivalent to K932467 (Instrumentation Laboratory CO, 1993) and 5 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1993.

Decided
Apr 21, 1998
Review
53 days
Class
Class II
Product code
CGZ
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K932467 (1993). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1995: 2 other ancestors1994: 1 other ancestorK932467 · Ilab 900/1800 Clinical Chemistry System · Instrumentation Laboratory CO · 1993199019921994199619982000
Other ancestors, by generation 1 generation back: 5 other ancestors K932467 · Ilab 900/1800 Clinical Chemistry System · Instrumentation Laboratory CO · 19930
  1. Root · 1 generation backK932467 Ilab 900/1800 Clinical Chemistry SystemInstrumentation Laboratory CO · 1993
  2. This deviceK980757 Ilab 600 Clinical Chemistry SystemInstrumentation Laboratory CO · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K932467Ilab 900/1800 Clinical Chemistry SystemInstrumentation Laboratory CO1993—
0 (this device)K980757Ilab 600 Clinical Chemistry SystemInstrumentation Laboratory CO1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199620
FIG. 1 — Lineage of K980757, 1993–1998Source: 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 CGZ? 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? (6)

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
*K932467Ilab 900/1800 Clinical Chemistry System
Summary page 2
…ayed) Sodium test system Triglyceride test system Urea nitrogen test system Uric acid test system Cholinesterase test system Identification of predicate device(s): K932467 K943595 K943366 K952646 K943367 K952647 ILab 900/1800 Clinical Chemistry System ILab 900/1800 Clinical Chemistry System — Urine…
Instrumentation Laboratory CO1993—
*K943595Serum/Urine Appli Ilab (TM) Clinical Chemistry System
Summary page 2
…dium test system Triglyceride test system Urea nitrogen test system Uric acid test system Cholinesterase test system Identification of predicate device(s): K932467 K943595 K943366 K952646 K943367 K952647 ILab 900/1800 Clinical Chemistry System ILab 900/1800 Clinical Chemistry System — Urine Claims…
Instrumentation Laboratory CO1994—
*K943366IL Test Acid Phosphatase
Summary page 2
…t system Triglyceride test system Urea nitrogen test system Uric acid test system Cholinesterase test system Identification of predicate device(s): K932467 K943595 K943366 K952646 K943367 K952647 ILab 900/1800 Clinical Chemistry System ILab 900/1800 Clinical Chemistry System — Urine Claims Added I…
Instrumentation Laboratory CO1996—
*K952646IL Test CK-MB
Summary page 2
…Triglyceride test system Urea nitrogen test system Uric acid test system Cholinesterase test system Identification of predicate device(s): K932467 K943595 K943366 K952646 K943367 K952647 ILab 900/1800 Clinical Chemistry System ILab 900/1800 Clinical Chemistry System — Urine Claims Added IL Test A…
Instrumentation Laboratory CO1995—
*K943367IL Test Cholinesterase
Summary page 2
…ceride test system Urea nitrogen test system Uric acid test system Cholinesterase test system Identification of predicate device(s): K932467 K943595 K943366 K952646 K943367 K952647 ILab 900/1800 Clinical Chemistry System ILab 900/1800 Clinical Chemistry System — Urine Claims Added IL Test Acid Phos…
Instrumentation Laboratory CO1996—
*K952647IL Test Lipase
Summary page 2
…est system Urea nitrogen test system Uric acid test system Cholinesterase test system Identification of predicate device(s): K932467 K943595 K943366 K952646 K943367 K952647 ILab 900/1800 Clinical Chemistry System ILab 900/1800 Clinical Chemistry System — Urine Claims Added IL Test Acid Phosphatase…
Instrumentation Laboratory CO1995—

Also cleared against K932467: 3 other devices →

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?

  • None of the 6 ancestors has a recall.
  • 3 other devices also cite its predicate K932467.

How does its category compare?

All CGZ devices

CGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGZ

1in 2018

2007: 12008: 22016: 12017: 12018: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGZ

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

Recalls per year · CGZ

2in 2019

2007: 12008: 12009: 12011: 12019: 2
2007high 2 (2019) · low 0 (2010)2026

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

Adverse event reports per year · CGZ

5in 2025

2007: 42009: 12010: 72011: 52012: 302013: 422014: 102015: 22016: 12017: 22018: 192019: 32020: 32022: 52023: 92024: 62025: 5
2007high 42 (2013) · low 0 (2008)2025

MAUDE reports naming product code CGZ, 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—14
20082—10
20090—11
20100—07
20110—15
20120—030
20130—042
20140—010
20150—02
20161—01
20171—02
20181—019
20190—23
20200—03
20210—00
20220—05
20230—09
20240—06
20250—05
20260—0—

What is it indicated for?

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

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 K932467

3 other devices cite the same predicate.

  • K974125IL Test AmylaseInstrumentation Laboratory CO · 1997
  • K974337IL Test Urea NitrogenInstrumentation Laboratory CO · 1997
  • K972363IL Test IronInstrumentation Laboratory CO · 1997

More from Instrumentation Laboratory CO

321 FDA decisions under this applicant name. See the company

  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023
  • K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
  • K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
  • K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO · 2022
  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 20222 recalls

Recent decisions in CGZ

The CGZ category page

  • K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU…Ortho-Clinical Diagnostics, Inc. · 20182 recalls
  • K170320Alinity c ICT Sample DiluentAbbott Laboratories · 2017
  • K162020VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics · 20162 recalls
  • K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131…Ortho-Clinical Diagnostics, Inc. · 2008
  • K070889Autodelfia Neonatal Irt L Kit, Model B022-112Wallac OY · 2008

https://510kreport.com/device/K980757 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980757: Ilab 600 Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980757

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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