The Beckman Vigil Hemoglobin A1c (HbA1c) Controls are designed for monitoring the reliability and overall performance of Beckman Hemoglobin A1c (HbA1c) test systems in the clinical laboratory. The use of two levels of control allows the laboratorian to monitor analytical error and imprecision.

Device Description

The Vigil HbA1c Controls are a two level lyophilized control set made from hemolyzed human and ovine blood. Each kit contains 3 X 1 mL bottles of each specific level of control. The levels are identified as Vigil HbA1c Control Level 1, and Vigil HbA1c Control Level 2. The products require reconstitution with exactly 1.0 mL of distilled water prior to use. The lyophilized products must be stored at +2℃ to +8℃ when not in use. The reconstituted controls are stable for 1 week at +2℃ to +8℃, 8 hours at +20℃ to +25℃, and 3 months when stored frozen between -15℃ to -20℃.

AI/ML Overview

The provided text is a 510(k) summary for the Beckman Coulter VIGIL™ HbA1c Controls, a quality control material. It details the device's description, intended use, and comparison to a predicate device, as well as a summary of performance data. However, the document does not describe specific acceptance criteria (numerical targets for performance metrics) or a detailed study proving the device meets those criteria in a way that aligns with the questions posed. The performance data section is very brief and focuses solely on stability studies, not on the precision or accuracy of the controls in monitoring HbA1c assays.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text.
Reported Device Performance: The document only provides data on "Stress stability studies of the lyophilized Vigil HbA1c Controls," and the conclusion is that these support a "Beckman stability claim of 24 months." No performance metrics like precision (e.g., CV%) or accuracy (e.g., bias) for the controls themselves when used in an HbA1c assay are provided.

Metric	Acceptance Criteria	Reported Device Performance
Stability at 25°C	Not specified	24 Months
Stability at 32°C	Not specified	24 Months
Stability at 37°C	Not specified	24 Months
Other performance	Not specified	Not reported

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The stability study mentions "Duration of Incubation" but not the number of samples tested at each duration.
Data Provenance: Not specified. The document is from Beckman Coulter, Inc. in Brea, California, USA, but it does not state where the study was conducted or the origin of the materials beyond being "hemolyzed human and ovine blood." Whether it was retrospective or prospective is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a quality control material, not an diagnostic algorithm requiring expert interpretation of results to establish ground truth for a test set. The performance data is solely related to the stability of the control material itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a quality control material, not an AI-assisted diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a quality control material, not a standalone algorithm/device in that sense. Its "performance" is in its stability and its ability to provide known values for monitoring other assays.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the stability study, the "ground truth" would be the known concentration of HbA1c in the control material at the beginning of the study, and subsequent measurements taken over time would be compared to this initial value (or a derived expected value) to assess stability within acceptable ranges (which are not specified). There is no mention of expert consensus, pathology, or outcomes data used for this control material.

8. The sample size for the training set

Not applicable. This is a quality control material and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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K987072

Beckman Coulter, Inc., Section 510(k) Notification VIGIL™ HbA1c Controls Summary of Safety & Effectiveness

JUL 6 1998

Summary of Safety & Effectiveness Beckman VIGIL™ HbA1c Controls

1.0 Submitted By:

Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

Date Submitted: 2.0

8 June 1998

Device Name(s): 3.0

3.1 Proprietary Names

VIGIL™ Hemoglobin A1c Controls

Classification Name 3.2

Quality Control Material (assayed and unassayed) (21 CFR § 862.1660)

Predicate Device(s): 4.0

BECKMAN Reagent	Predicate	Predicate Company	Docket Number
Vigil TM HbA1c Controls	Boehringer MannheimTina-quant®Hemoglobin A1c assay	BoehringerMannheim	K934070

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Beckman Coulter, Inc., Section 510(k) Notification VIGIL™ HbA1c Controls Summary of Safety & Effectiveness

5.0 Description:

"The Vigil HbA1c Controls are a two level lyophilized control set made from hemolyzed human and ovine blood. Each kit contains 3 X 1 mL bottles of each specific level of control. The levels are identified as Vigil HbA1c Control Level 1, and Vigil HbA1c Control Level 2. The products require reconstitution with exactly 1.0 mL of distilled water prior to use. The lyophilized products must be stored at +2℃ to +8℃ when not in use. The reconstituted controls are stable for 1 week at +2℃ to +8℃, 8 hours at +20℃ to +25℃, and 3 months when stored frozen between -15℃ to -20℃.

6.0 · Intended Use:

The Vigil™ HbA1c Controls are designed for monitoring the overall reliability of HbA1c assays on SYNCHRON CX® and LX™ Systems.

Comparison to Predicate(s): 7.0

Boehringer Mannheim Corporation manufactures the Vigil™ HbA1c controls for Beckman Coulter, Inc. Boehringer Mannheim has clearance to market these products under the names Precinorm® HbA1c and Precipath® HbA1c. Beckman Coulter, Inc. labels are placed on the product and Beckman assigns SYNCHRON® Systems values to the product.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the Vigil HbA1c Controls to the Boehringer Mannheim Precinorm® and Precipath®. Stress stability studies of the lyophilized Vigil HbA1c Controls support the Beckman stability claim of 24 months.

Stress Temperature	Duration of Incubation	Beckman Stability Claim*
25°C	65 Days	24 Months
32°C	30 Days	24 Months
37°C	18 Days	24 Months

Vigil HbA1c Controls Stability Study Summary

*Expiration dating placed on the package based on date of manufacture

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

6 1998 . IUL

Lucinda Stockert Staff Requlatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, M/S W-104 P.O. Box 800 Brea, California 92822-8000

K982022 Re : VIGIL™ HbAlc Controls Requlatory Class: I Product Code: JJX Dated: June 8, 1998 Received: June 9, 1998

Dear Ms. Stockert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Attachment 2

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510(k) Number (if known): Not yet assigned

Device Name: VIGIL™ HbA1c Controls

Indications for Use:

21 CFR 862.1660 Quality Control Material (assayed and unassayed)

(a) Identification. A quality control material (assayed and unassayed) is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

(b) Classification. Class I.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	1982022

Prescription Use
(per 21 CFR 801.109)

Over-the-Counter Use
Optional Format 1-2-96

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.