510(k) Report

510(k) · Cleared

Recalled · 2007

Liquid Alt (SGPT) Reagent Set

K941287510(k) TraditionalCleared May 3, 199447-day reviewClass I21 CFR 862.1030Recalls 8

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

Pointe Scientific, Inc., · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

Cleared on May 3, 1994 after a 47-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 8 times.

Decided
May 3, 1994
Review
47 days
Class
Class I
Product code
CKA
Recalls
8
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K941287Source: FDA 510(k) database · 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 14, 2007Not classifiedZ-1113-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1111-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1116-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1117-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1114-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1110-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1115-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007Not classifiedZ-1112-2008Process controlFailure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CKA devices

CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKA

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CKA

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

Recalls per year · CKA

1in 2016

2007: 82010: 12016: 1
2007high 8 (2007) · low 0 (2008)2026

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

Adverse event reports per year · CKA

8in 2025

2010: 82011: 392012: 82017: 22018: 12020: 32021: 22022: 22023: 42024: 102025: 8
2007high 39 (2011) · low 0 (2007)2025

MAUDE reports naming product code CKA, 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—80
20080—00
20090—00
20100—18
20110—039
20121—08
20131—00
20140—00
20150—00
20160—10
20170—02
20180—01
20190—00
20200—03
20210—02
20220—02
20230—04
20240—010
20250—08
20260—0—

More from Pointe Scientific, Inc.,

74 FDA decisions under this applicant name. See the company

  • K070757Microprotein Reagent SetPointe Scientific, Inc., · 2007
  • K062118Pointe 360Pointe Scientific, Inc., · 2007
  • K070251Carbon Dioxide Liquid Stable ReagentPointe Scientific, Inc., · 2007
  • K070207Multi-Analyte Chemistry CalibratorPointe Scientific, Inc., · 2007
  • K070504Ammonia/Alcohol Control SetPointe Scientific, Inc., · 2007

Recent decisions in CKA

The CKA category page

  • K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge AstHitachi Chemical Diagnostics, Inc. · 2013
  • K113382Ace Alt ReagentAlfa Wassermann · 20121 recall
  • K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino…Dade Behring, Inc. · 20061 recall
  • K020487Careside AltCareside, Inc. · 2002
  • K980028Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)Trace America, Inc. · 1998

https://510kreport.com/device/K941287 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941287: Liquid Alt (SGPT) Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941287

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026