510(k) Report

510(k) · Cleared

Recalled · 2011

DSL Active Ifgbp-3 Elisa

K951707510(k) TraditionalCleared May 10, 199527-day reviewClass I21 CFR 862.1370Recalls 1

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

Diagnostic Systems Laboratories, Inc. · CFL Radioimmunoassay, Human Growth Hormone

Cleared on May 10, 1995 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
May 10, 1995
Review
27 days
Class
Class I
Product code
CFL
Recalls
1
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K951707Source: 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 has not posted a summary or statement for it, 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
Mar 30, 2011Not classifiedZ-2184-2011Process controlThe recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).

No ancestor or descendant has a Class I recall.

How does its category compare?

All CFL devices

CFL Radioimmunoassay, Human Growth Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFL

FDA has decided no CFL device since 2007.

Median 510(k) review, days · CFL

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

Recalls per year · CFL

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · CFL

11in 2025

2007: 12010: 22011: 12012: 182016: 22017: 72018: 102019: 22020: 22021: 22022: 62023: 42024: 52025: 11
2007high 18 (2012) · low 0 (2008)2025

MAUDE reports naming product code CFL, 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—01
20080—00
20090—00
20100—12
20110—11
20120—018
20130—00
20140—00
20150—00
20160—02
20170—07
20180—010
20190—02
20200—02
20210—02
20220—06
20230—04
20240—05
20250—011
20260—0—

More from Diagnostic Systems Laboratories, Inc.

94 FDA decisions under this applicant name. See the company

  • K061758Active Renin IrmaDiagnostic Systems Laboratories, Inc. · 2006
  • K020945Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc. · 2002
  • K020128Active Free Beta-HCG Elisa, Model DSL-10-8500Diagnostic Systems Laboratories, Inc. · 2002
  • K002128Active Inhibin-a Elisa, Model DSL-10-28100Diagnostic Systems Laboratories, Inc. · 20004 recalls
  • K001086Free Testosterone Enzyme Immunoassay, Model DSL-10-4900Diagnostic Systems Laboratories, Inc. · 2000

Recent decisions in CFL

The CFL category page

  • K972761Sealite Sciences, Inc. Aqualite Human Growth Hormone AssaySealite Sciences, Inc. · 1997
  • K971353DSL Active Non-Extraction Igf-I ElisaDiagnostic Systems Laboratories, Inc. · 1997
  • K970701DSL 1900 Active Human Growth Hormone Irma (DSL 1900)Diagnostic Systems Laboratories, Inc. · 1997
  • K962758DSL 9100 Igf-II IrmaDiagnostic Systems Laboratories, Inc. · 1996
  • K961678Human Growth Hormone Immunoassay KitNichols Institute Diagnostics · 1996

https://510kreport.com/device/K951707 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951707: DSL Active Ifgbp-3 Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951707

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