Abbott Tumor Marker – MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Description

Abbott Tumor Marker - MCC (Lyophilized) is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability

AI/ML Overview

The provided document is a Premarket Notification (510(k)) for the Abbott Tumor Marker - MCC (Lyophilized). It describes a quality control serum, not a diagnostic device with performance metrics typical of AI/ML or medical imaging studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable (N/A) to this type of submission.

Here's the information that can be extracted and a clear indication of N/A for the others:

Acceptance Criteria and Device Performance for Abbott Tumor Marker - MCC (Lyophilized)

This submission focuses on establishing substantial equivalence for a quality control serum, primarily by demonstrating its stability. The "acceptance criteria" here relate to the duration of stability under different storage and use conditions.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Claimed Stability)	Reported Device Performance (Summary of Performance Data)
Open Vial Stability	All analytes stable for 14 days at 2-8°C (tightly capped), except Free PSA and PSA (should be assayed immediately after reconstitution).	Met the claimed stability: "Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 - 8℃, with the following exceptions: Free PSA and PSA should be assayed immediately following reconstitution."
Reconstituted Frozen Stability	All analytes stable for 30 days at -10°C to -20°C (tightly capped/frozen). Once thawed, do not refreeze.	Met the claimed stability: "After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10℃ to -20℃. Once thawed, do not refreeze the control; discard remaining material." (Improved from predicate device's 20 days for PSA).
Unopened Shelf Life	Stable for 3 years and 3 months when stored unopened at 2-8°C.	Met the claimed stability: "The control is stable for 3 years and 3 months when stored unopened at 2 - 8℃." Note: "Real time studies will be ongoing to support the shelf life of this product."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of number of individual samples, but refers to "stability studies" performed on the control product itself. This is typical for quality control product validation, where samples are tested at various time points and conditions.
Data Provenance: Not specified, but generally, such studies for device premarket notifications are conducted internally by the manufacturer (Bio-Rad Laboratories in this case) under controlled laboratory conditions, likely in the US as the submission is to the FDA. Retrospective/prospective is not applicable in the context of stability testing (it's a prospective design to observe changes over time).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth in this context is not established by human experts interpreting data. Instead, it's determined by analytical testing methods to assess the analyte concentrations and their stability within the control material, measured against established reference values or specifications for the manufacturing process.

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

N/A. Adjudication is not relevant for stability studies of a quality control product. The "truth" is determined by direct analytical measurement and statistical evaluation of stability data.

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

N/A. This is not an AI/ML diagnostic device, and thus no MRMC study with human readers or AI assistance was performed.

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

N/A. Not an algorithm or AI device.

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

The "ground truth" for this device's performance is its measured stability characteristics (e.g., analyte concentrations remaining within acceptable ranges, physical properties unchanged) over time and under specified storage/use conditions, as determined by laboratory analytical methods. It's an internal QC/assay performance metric, not a clinical ground truth.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

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

N/A. Not an AI/ML device.

Summary

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Bio-Rad Laboratories Premarket Notification Section 510(k) for Abbott Turnor Marker -- MCC (Lyophilized) Summary of Safety and Effectiveness

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Page 1 of 3

Summary of Safety and Effectiveness Abbott Tumor Marker - MCC (Lyophilized)

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555

Contact Person

Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465

Date of Summary Preparation

June 06, 2001

2.0 Device Identification

Product Trade Name: Abbott Tumor Marker - MCC (Lyophilized)

Common Name: Multi-Analyte Controls, (Assayed and unassayed)

Classifications: Class I Product Code: 75JJY Regulation Number: CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

Abbott Tumor Marker - MCC (Lyophilized) Bio-Rad Laboratories Irvine, California

Docket Number: K990610

4.0 Description of Device

Abbott Tumor Marker - MCC (Lyophilized) is prepared from human serum with added constituents of human origin and pure chemicals.

The control is provided in lyophilized form for increased stability

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5.0 Statement of Intended Use

Abbott Tumor Marker - MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.

6.0 Comparison of the new device with the Predicate Device

The new Abbott Tumor Marker – MCC (Lyophilized) claims substantial equivalence to the Abbott Tumor Marker -- MCC (Lyophilized) currently in commercial distribution (K990610). The new Abbott Tumor Marker - MCC (Lyophilized) contains all the analytes as the predicate device plus B2 Microglobulin and PAP. The new device has improved reconstituted freeze-thaw stability claims for PSA.

	Abbott	Abbott
Characteristics	Tumor Marker - MCC (Lyophilized)(New Device)	Tumor Marker - MCC (Lyophilized)(Predicate Device)
Similarities
Intended Use	Tumor Marker - MCC(Lyophilized) is intended for useas a quality control serum tomonitor the precision of laboratorytesting procedures for theanalytes listed in the packageinsert.	Tumor Marker - MCC(Lyophilized) is intended for use asa quality control serum to monitorthe precision of laboratory testingprocedures for the analytes listedin the package insert.
Form	Lyophilized	Lyophilized
Matrix	Human serum based	Human serum based
OpenVial Claim	All analytes will be stable for 14days when stored at 2 – 8°Ctightly capped with the followingexceptions: Free PSA and PSAshould be assayed immediatelyfollowing reconstitution.	All analytes will be stable for 14days when stored at 2 - 8°C tightlycapped with the followingexceptions: Free PSA and PSAshould be assayed immediatelyfollowing reconstitution.
Storage(Unopened)	2°C to 8°Cuntil expiration date	2°C to 8°Cuntil expiration date

Table 1. Similarities and Differences between new and predicate device.

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Differences
AnalytesClaimed	All the same analytes as thecurrent Abbott Tumor Marker -MCC (Lyophilized), plus B2Microglobulin and PAP.	AFP, CA 15-3, CA 19-9, CA 125,CEA, Free PSA, PSA.
ReconstitutedFreeze VialClaim	All analytes will be stable afterreconstituting and freezing for 30days when stored at -10°C to -20°C.	All analytes will be stable for 30days after reconstituting andfreezing when stored at -10°C to -20°C, with the followingexceptions: (1) PSA will be stablefor 20 days.

Table 1. Similarities and Differences between new and predicate device, continued.

7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Abbott Tumor Marker - MCC (Lyophilized). Product claims are as follows:

Once the control is reconstituted, all analytes will be stable for 14 days 7.1 when stored tightly capped at 2 - 8℃, with the following exceptions: Free PSA and PSA should be assayed immediately following reconstitution.
After reconstituting and freezing the control, all analytes will be stable for 7.2 30 days when stored tightly capped at -10℃ to -20℃. Once thawed, do not refreeze the control; discard remaining material.
The control is stable for 3 years and 3 months when stored unopened at 2 7.3 - 8℃.

Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 2001

Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017

510(K) Number: K011853 Re: 510(11) Frade/Device Name: Abbott Tumor Marker - MCC (Lyophilized) Regulation Number: 862.1160 Regulatory Class: I Product Code: JJY Dated: June 6, 2001 Received: June 13, 2001

Dear Ms. Chapman:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becally in the substantially equivalent (for the indications for use above and we nave determined the actives marketed predicate devices marketed in interstate commerce stated in the encrosure) to legally manetes of the Medical Device Amendments, or to devices that provity 20, 1970, are encounces with the provisions of the Federal Food, Drug, and Tiave been tectassified in accordance market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general controliberturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see associates and additional controls. Existing major regulations (Fremarks Approvary, it the Code of Federal Regulations, Title 21, Parts 800 to 895. affecting your do rios can determination assumes compliance with the Current Good A substantany equirements, as set forth in the Quality System Regulation (QS) for Manufacturing Fraction regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to inspections, the Food and Drug result in regulatory action. In addition, FDA may publish comply with the GMT regaration in our device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and in you to objak antial equivalence of your device to a legally marketed noutication. The I Drice results in for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific active for your atic devices), please contact the Office of Compliance at additionally 007.10 for mirring and stimment on the promotion and advertising of your device, (301) 591 1500: Traditionally, at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your rooperation.oll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

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510 (k) Number (if known):_ 竹O川8S3

Abbott Tumor Marker - MCC (Lyophilized) Device Name:

Indications for Use:

Abbott Tumor Marker – MCC (Lyophilized) is intended for use as an assayed Abbott Tamor Mariotr the precision of laboratory testing procedures for the analytes listed in the insert.

Jacket

(Division/Sign-Off) Division Laboratory Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use or

Over-the Counter use

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.