510(k) Report

510(k) · Cleared

Cleared

Accessa Cholesterol Panel

K063852510(k) TraditionalCleared Nov 9, 2007316-day reviewClass II21 CFR 862.1675

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

Home Access Health Corp. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Nov 9, 2007 as substantially equivalent to K012221 (Biosafe Laboratories, Inc., 2002) and 3 other predicates after a 316-day review. Its family tree reaches back 2 generations to 1979.

Decided
Nov 9, 2007
Review
316 days
Class
Class II
Product code
JKA
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K781939 (1979). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1989: 1 other ancestor1980: 2 other ancestors1997: 1 other ancestor1993: 1 other ancestorK781939 · Reagent Kit, Triglycerides · Beckman Instruments, Inc. · 1979K012221 · Safe at Home Cholesterol Profile Blood Collection and Transport System · Biosafe Laboratories, Inc. · 20021975198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K012221 · Safe at Home Cholesterol Profile Blood Collection and Transport System · Biosafe Laboratories, Inc. · 2002K781939 · Reagent Kit, Triglycerides · Beckman Instruments, Inc. · 19790
  1. Root · 2 generations backK781939 Reagent Kit, TriglyceridesBeckman Instruments, Inc. · 1979
  2. 1 generation backK012221 Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002
  3. This deviceK063852 Accessa Cholesterol PanelHome Access Health Corp. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K781939Reagent Kit, TriglyceridesBeckman Instruments, Inc.1979—
−1K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc.2002—
0 (this device)K063852Accessa Cholesterol PanelHome Access Health Corp.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
198910
199310
199710
FIG. 1 — Lineage of K063852, 1979–2007Source: 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 JKA? 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 JKA device

  1. #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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? (4)

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
*K012221Safe at Home Cholesterol Profile Blood Collection and Transport System
Summary page 1
…LDL Cholesterol (21CFR 862.1475) Predicate Devices: Predicate Device: Safe At Home Cholesterol Profile K012221 manufactured by BIOSAFE Laboratories, Inc. Predicate Test…
Biosafe Laboratories, Inc.2002—
*K891922Amresco Cholesterol Reagents, Prod. # 7325
Summary page 1
…factured by BIOSAFE Laboratories, Inc. Predicate Test Methods: * Total Cholesterol: Amresco Cholesterol Reagent Assay K891922 * HDL Cholesterol: Wako L-Type HDL-C Reagent Assay K801834 * Triglyceride…
American Research Products Co.1989—
*K801834Wako HDL Cholesterol Test
Summary page 1
…* Total Cholesterol: Amresco Cholesterol Reagent Assay K891922 * HDL Cholesterol: Wako L-Type HDL-C Reagent Assay K801834 * Triglycerides: Roche Triglycerides K801298 Device Description: The accessa Cholesterol Panel i…
Wako Pure Chemical Industries, Ltd.1980—
*K801298Cobas Reagent for Triglycerides & Cobas
Summary page 1
…Assay K891922 * HDL Cholesterol: Wako L-Type HDL-C Reagent Assay K801834 * Triglycerides: Roche Triglycerides K801298 Device Description: The accessa Cholesterol Panel incorporates the use of two separately regulated products.…
Roche Analytical Instruments, Inc.1980—

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 28 years and passes through 3 companies; a new generation was cleared every 23.2 years on median.
  • None of the 7 ancestors has a recall.

How does its category compare?

All JKA devices

JKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JKA

7in 2025

2007: 42008: 22009: 22010: 42012: 12013: 32014: 12015: 12016: 42017: 22018: 12019: 62020: 62021: 42022: 92023: 172024: 62025: 72026 (partial year): 8
2007high 17 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKA

115in 2025

2007: 281 days median2010: 28 days median2013: 244 days median2016: 116 days median2019: 181 days median2020: 181 days median2021: 217 days median2022: 164 days median2023: 189 days median2024: 240 days median2025: 115 days median2026 (partial year): 250 days median
2007high 281 (2007) · low 28 (2010)2026

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

Recalls per year · JKA

13in 2025

2007: 32008: 32009: 32010: 42011: 142012: 22013: 12014: 12015: 62016: 12017: 22018: 22019: 92021: 32022: 22023: 22025: 132026 (partial year): 1
2007high 14 (2011) · low 0 (2020)2026

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

Adverse event reports per year · JKA

6,089in 2025

2007: 732008: 782009: 422010: 372011: 672012: 542013: 332014: 682015: 412016: 652017: 2,0392018: 9,7312019: 6,4692020: 3,7742021: 3,6102022: 3,3752023: 4,4002024: 4,6092025: 6,089
2007high 9,731 (2018) · low 33 (2013)2025

MAUDE reports naming product code JKA, 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
20074281373
20082—378
20092—342
2010428437
20110—1467
20121—254
20133244133
20141—168
20151—641
20164116165
20172—22,039
20181—29,731
2019618196,469
2020618103,774
2021421733,610
2022916423,375
20231718924,400
2024624004,609
20257115136,089
202682501—

What is it indicated for?

The accessa Cholesterol Panel is intended for in vitro, quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and calculated LDL-Cholesterol in dried micro-serum samples ("Cholesterol Panel"). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of…

Read the full statement (94 words)

The accessa Cholesterol Panel is intended for in vitro, quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and calculated LDL-Cholesterol in dried micro-serum samples ("Cholesterol Panel"). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. The Cholesterol Panel is not intended for use on neonates. LDL-Cholesterol cannot be determined where the triglycerides value is greater than 400 mg/dL.

Indications for use as stated in the FDA summary.

More from Home Access Health Corp.

2 FDA decisions under this applicant name. See the company

  • K141944Home Access Aic TestHome Access Health Corp. · 2015

Recent decisions in JKA

The JKA category page

  • K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2026
  • K252344BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)Becton, Dickinson and Company · 2026
  • K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd. · 2026
  • K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd. · 2026
  • K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026

https://510kreport.com/device/K063852 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063852: Accessa Cholesterol Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063852

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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