510(k) Report

510(k) · Cleared

Cleared

Precision A1C Home HBA1C Sample Collection Kit

K983253510(k) TraditionalCleared Nov 20, 199865-day reviewClass II21 CFR 864.7470

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

Medisense, Inc. · LCP Assay, Glycosylated Hemoglobin

Cleared on Nov 20, 1998 as substantially equivalent to K971919 (Flexsite Diagnostics, Inc., 1997) and 2 other predicates after a 65-day review. Its family tree reaches back 3 generations to 1986.

Decided
Nov 20, 1998
Review
65 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K861697 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorReference device: K961824 · Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin · Roche Diagnostic Systems, Inc. · 1996Reference device: K952337 · Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P · Roche Diagnostic Systems, Inc. · 1996 · recalledReference device: K851636 · Diamat Glycoslated Hemoglobin Analyzer System · Bio-Rad · 1985K861697 · Self Assure/GHB (Capillary-Blood Collection Kit) · Awareness Technology, Inc. · 1986K971919 · Ezchek/Hba Blood Collection Kit · Flexsite Diagnostics, Inc. · 1997K974491 · Accu-Chek A1C Hemoglobin Test · Boehringer Mannheim Corp. · 19981985199019952000
Other ancestors, by generation 2 generations back: 1 other ancestor K974491 · Accu-Chek A1C Hemoglobin Test · Boehringer Mannheim Corp. · 1998K971919 · Ezchek/Hba Blood Collection Kit · Flexsite Diagnostics, Inc. · 1997K861697 · Self Assure/GHB (Capillary-Blood Collection Kit) · Awareness Technology, Inc. · 19860
  1. Root · 3 generations backK861697 Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 1986
  2. 2 generations backK971919 Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997
  3. 1 generation backK974491 Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp. · 1998
  4. This deviceK983253 Precision A1C Home HBA1C Sample Collection KitMedisense, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K861697Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc.1986—
−2K971919Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc.1997—
−1K974491Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp.1998—
0 (this device)K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K983253, 1986–1998Source: 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 LCP? 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 LCP device

  1. #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 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
*K971919Ezchek/Hba Blood Collection Kit
Summary page 1
…) capillary blood sample collection kit; dried blood spot (DBS) card Glycosylated Hemoglobin Assay (Class II per 21 CFR 864.7470) EZCHEK™/HbA1c¢ Sample Collection Kit--K971919 Self-Assure®/GHb--K861697/A Accu-Chek™ Alc Hemoglobin Test--K974491 Roche Cobas® Integra HbA1c--K961824 Roche Unimate HbA1c Re…
Flexsite Diagnostics, Inc.1997—
*K861697Self Assure/GHB (Capillary-Blood Collection Kit)
Summary page 1
…ollection kit; dried blood spot (DBS) card Glycosylated Hemoglobin Assay (Class II per 21 CFR 864.7470) EZCHEK™/HbA1c¢ Sample Collection Kit--K971919 Self-Assure®/GHb--K861697/A Accu-Chek™ Alc Hemoglobin Test--K974491 Roche Cobas® Integra HbA1c--K961824 Roche Unimate HbA1c Reagent--K952337/S1 Bio-Rad…
Awareness Technology, Inc.1986—
*K974491Accu-Chek A1C Hemoglobin Test
Summary page 1
…Glycosylated Hemoglobin Assay (Class II per 21 CFR 864.7470) EZCHEK™/HbA1c¢ Sample Collection Kit--K971919 Self-Assure®/GHb--K861697/A Accu-Chek™ Alc Hemoglobin Test--K974491 Roche Cobas® Integra HbA1c--K961824 Roche Unimate HbA1c Reagent--K952337/S1 Bio-Rad Diamat Glycosylated Hemoglobin Analyzer Sy…
Boehringer Mannheim Corp.1998—
†K961824Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc.1996—
†K952337Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & PRoche Diagnostic Systems, Inc.19962
†K851636Diamat Glycoslated Hemoglobin Analyzer SystemBio-Rad1985—

Also cleared against K971919: 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?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 8 months on median.
  • None of the 4 ancestors has a recall.
  • 5 other devices also cite its predicate K971919.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCP

1in 2024

2007: 72008: 52009: 62010: 22011: 102012: 92013: 22014: 82015: 32016: 22017: 52018: 22019: 42020: 12023: 22024: 1
2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007: 133 days median2008: 206 days median2009: 158 days median2011: 176 days median2012: 143 days median2014: 127 days median2015: 239 days median2017: 218 days median2019: 269 days median
2007high 269 (2019) · low 127 (2014)2026

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

Recalls per year · LCP

1in 2025

2007: 12008: 32009: 62010: 52011: 512013: 42014: 22015: 22016: 62017: 12018: 12022: 12024: 12025: 1
2007high 51 (2011) · low 0 (2012)2026

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

Adverse event reports per year · LCP

22in 2025

2007: 52008: 112009: 152010: 42011: 272012: 512013: 1932014: 1822015: 642016: 292017: 1492018: 1,9112019: 1142020: 132021: 72022: 82023: 272024: 392025: 22
2007high 1,911 (2018) · low 4 (2010)2025

MAUDE reports naming product code LCP, 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
2007713315
20085206311
20096158615
20102—54
2011101765127
20129143051
20132—4193
201481272182
20153239264
20162—629
201752181149
20182—11,911
201942690114
20201—013
20210—07
20220—18
20232—027
20241—139
20250—122
20260—0—

What is it indicated for?

The Precision Alc Home HbAlc Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbAlc (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus.

The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

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 K971919

5 other devices cite the same predicate.

  • K990899Hemochek-A1C Sample Collection KitOsborn Group, Inc. · 199934 recalls
  • K991850Safe at-Home Test Kit for Monitoring Hemoglobin AlcBiosafe Laboratories, Inc. · 1999
  • K984529Hemochek Sample Collection KitOsborn Laboratories, Inc. · 1999
  • K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998
  • K974491Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp. · 1998

More from Medisense, Inc.

15 FDA decisions under this applicant name. See the company

  • K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra…Medisense, Inc. · 19991 recall
  • K982303Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood…Medisense, Inc. · 1998
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997
  • K963676Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  • K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996

Recent decisions in LCP

The LCP category page

  • K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  • K231465Q-Pad Test SystemQurasense · 2023
  • K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
  • K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020
  • K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd. · 2019

https://510kreport.com/device/K983253 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983253: Precision A1C Home HBA1C Sample Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983253

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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