510(k) Report

510(k) · Cleared

Cleared

Excel GE Blood Glucose Test Strips & Code Strip

K991480510(k) TraditionalCleared Sep 17, 1999142-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

Selfcare, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Sep 17, 1999 as substantially equivalent to K964630 (Bayer Corp., 1997) and 2 other predicates after a 142-day review. Its family tree reaches back 1 generation to 1992.

Decided
Sep 17, 1999
Review
142 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K924499 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1995: 1 other ancestorK924499 · Elite Test Strips Glucometer · Heraeus Kulzer, Inc. · 1992199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K924499 · Elite Test Strips Glucometer · Heraeus Kulzer, Inc. · 19920
  1. Root · 1 generation backK924499 Elite Test Strips GlucometerHeraeus Kulzer, Inc. · 1992
  2. This deviceK991480 Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924499Elite Test Strips GlucometerHeraeus Kulzer, Inc.1992—
0 (this device)K991480Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
FIG. 1 — Lineage of K991480, 1992–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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? (3)

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
*K964630Glucometer Elite Blood Glucose Meter
Summary page 1
…edicate device, Glucometer Elite® Blood Glucose Test Strips and Code Strip. The predicate device is distributed by Bayer and was cleared for use in the United States by K964630, K951537 and K924499. Description of the device/intended use(s): Excel ™ GE Blood Glucose Test Strips quantitatively measure gl…
Bayer Corp.1997—
*K951537Glucometer Elite M Blood Glucose Meter
Summary page 1
…evice, Glucometer Elite® Blood Glucose Test Strips and Code Strip. The predicate device is distributed by Bayer and was cleared for use in the United States by K964630, K951537 and K924499. Description of the device/intended use(s): Excel ™ GE Blood Glucose Test Strips quantitatively measure glucose in…
Bayer Corp.1995—
*K924499Elite Test Strips Glucometer
Summary page 1
…meter Elite® Blood Glucose Test Strips and Code Strip. The predicate device is distributed by Bayer and was cleared for use in the United States by K964630, K951537 and K924499. Description of the device/intended use(s): Excel ™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capill…
Heraeus Kulzer, Inc.1992—

Also cleared against K964630: 5 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 3 ancestors has a recall.
  • 5 other devices also cite its predicate K964630.

How does its category compare?

All CGA devices

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

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.

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 K964630

5 other devices cite the same predicate.

  • K061234Glucoplus Blood Glucose Monitoring SystemGlucoplus, Inc. · 2006
  • K0502243TEST Glucose Monitoring SystemNeuero Engineering, Inc. · 2005
  • K043340EZ SmartVip Diagnostics, LLC · 2005
  • K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
  • K040848EZ SmartVip International Wholesalers, Corp. · 2004

More from Selfcare, Inc.

15 FDA decisions under this applicant name. See the company

  • K002867Inverness Medical Ovulation Predictor TestSelfcare, Inc. · 2000
  • K002134One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
  • K002049Inverness Medical Early Pregnancy TestSelfcare, Inc. · 2000
  • K001427Modification to Fasttake Compact Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
  • K000583Fasttake Compact Blood Glucose Monitoring SystemSelfcare, Inc. · 2000

Recent decisions in CGA

The CGA category page

  • K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
  • K220328EasyStat 300Medica Corporation · 2024
  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K991480 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991480: Excel GE Blood Glucose Test Strips & Code Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991480

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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