ELECSYS CALCHECK FOLATE by BOEHRINGER MANNHEIM CORP.

Elecsys CalCheck Folate calibration verification solutions comprise three levels - low, mid, and high - each with a defined Folate concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys CalCheck Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.

Device Description

The Boehringer Mannheim Elecsys® CalCheck™ Folate is manufactured using human serum albumin, Folate, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards.

AI/ML Overview

This looks like a 510(k) premarket notification for a calibration verification material, not a medical device that diagnoses or treats patients and therefore the typical "acceptance criteria" and "device performance" in terms of clinical accuracy (sensitivity, specificity, etc.) with human-in-the-loop or standalone studies are not applicable in the same way.

Instead, the "acceptance criteria" and "device performance" for a calibration verification material like the Elecsys® CalCheck™ Folate would relate to its ability to accurately verify the calibration of an assay, its stability, and consistency of its assigned values.

However, based on the provided text, the specific acceptance criteria and the detailed study results that prove the device meets these criteria are not explicitly stated. The document mentions that performance characteristics were evaluated for "value assignment and stability" but does not provide the numerical results or the methodology in detail within the provided snippets.

Therefore, many of the requested fields cannot be fully populated. Here's what can be inferred or stated based on the provided text:

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

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred/Stated)
Accurate value assignment for Folate concentration levels.	"The Elecsys® CalCheck™ Folate was evaluated for value assignment..." (Details of specific values or acceptable ranges are not provided in the given text). The device is manufactured with the analyte "appropriately spiked into the calcheck matrix to the correct calcheck concentration levels," and "in process checked and quality controlled against in-house standards." (This implies a successful value assignment, but specific performance data is missing).
Stability of Folate concentration over time.	"...and stability." (Details of stability duration, conditions, and acceptable deviation are not provided in the given text.)
Substantial equivalence to predicate device (Elecsys® CalCheck™ TSH).	The FDA found the device "substantially equivalent" to the predicate device. The document explicitly states: "The Boehringer Mannheim Elecsys® CalCheck™ Folate is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147)."

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

Sample Size: Not specified in the provided text. The evaluation report mentioned "value assignment and stability" but no sample sizes for these studies are indicated.
Data Provenance: Not specified. It's likely internal testing performed by Boehringer Mannheim Corporation (based in Pleasanton, CA, USA), but this is not explicitly stated as the origin of the data. The study type (retrospective/prospective) is also not stated.

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)

This type of expert ground truth is not applicable for a calibration verification material. The "ground truth" for the a calibration verification material is the precisely known concentration of the analyte within the material, established through rigorous analytical measurement and manufacturing processes. The document mentions "in process checked and quality controlled against in-house standards."

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

Not applicable as it's not a diagnostic device requiring human interpretation for ground truth.

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 calibration verification material, not an AI-powered diagnostic device.

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

Not applicable in the context of typical diagnostic algorithms. The device itself (the CalCheck material) is a standalone product to verify an assay's performance. The "performance" assessment ("value assignment" and "stability") would inherently be a standalone evaluation of the material itself.

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

For the Elecsys® CalCheck™ Folate, the "ground truth" would be the analytically determined and assigned concentration of Folate within each of the three CalCheck levels. This is established through the manufacturing process, spiking the analyte to "correct calcheck concentration levels," and subsequent quality control processes using "in-house standards."

8. The sample size for the training set

Not applicable for this type of device. There is no machine learning "training set."

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

Not applicable for this type of device.

Summary

{0}------------------------------------------------

K174384

DEC - 8 1997

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1.Submitter name, address, contact	Boehringer Mannheim Corporation4300 Hacienda DrivePleasanton, CA 94588-2722(510) 730- 8215Fax number: (510)-225-0654Contact Person: Patricia M. KlimleyDate Prepared: November 14, 1997
2.Device Name	Proprietary name: Elecsys® CalCheck™ FolateCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed)
3.Predicate device	The Boehringer Mannheim Elecsys® CalCheck™ Folate is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147).
4.Device Description	The Boehringer Mannheim Elecsys® CalCheck™ Folate is manufactured using human serum albumin, Folate, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards.
	Continued on next page

510(k) Summary

・

{1}------------------------------------------------

510(k) Summary, Continued

5.Intended use	The Boehringer Mannheim Elecsys® CalCheck™ Folate is used to verify thecalibration assignment for the Boehringer Mannheim Elecsys Folate assay.
6.Comparison topredicatedevice	The Boehringer Mannheim Elecsys® CalCheck™ Folate is substantiallyequivalent to other products in commercial distribution intended for similaruse. Most notably, it is substantially equivalent to the currently marketedElecsys® CalCheck™ TSH Calibration Verification Test (K963147).
	Both products are intended to be used for the verification of calibration foranalytes on automated immunoassay analyzers.
	The following table compares the Elecsys® CalCheck™ Folate with thepredicate device, Elecsys® CalCheck™ TSH. Specific data on theperformance of the test have been incorporated into the draft labeling inattachment 5. Labeling for the predicate devices is provided in attachment 6.
	Similarities:
	• Configuration: Three CalCheck levels: low, mid, and high
	• Intended use: To verify calibration

Differences:

LEAR READ MILLING-------LA SERIE CLANDE FOR1 000	------------BORE -- -- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	And Property of Children Company ofThe Property of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sun Manager Station of Children Collection of Children Collection of Children Company of Children Company of Children Company of Children of Children of Children of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------· RADITAccession as a	------------------------------um albumin Ho1	LE MALE MINNER AN---------
Concession*****1LA SERVICE SECREE------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CarolinaI	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A L MORE AND AND------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of the climit of the program a-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Performance
Characteristics

The Elecsys® CalCheck™ Folate was evaluated for value assignment and stability.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 8 K

Patricia M. Klimley .Requlatory Affairs Manager Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

K974384 Re : Elecsys® CalCheck™ Folate Product Code: JJY Requlatory Class: I Dated: November 20, 1997 Received: November 21, 1997

Dear Ms. Klimley:

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 of the Act. The general controls provisions 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 regulations.

{3}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): N/A

K974384

Device Name: Boehringer Mannheim Elecsys® CalCheck™ Folate

Indications For Use:

The Elecsys CalCheck Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

ivision Sign-Off)
Division of Clinical Laboratory
10(k) Number K974384

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.