Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1 (APO-A1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-Binding Capacity, Total (TIBC), Iron-Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.

Device Description

Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mission CliniCheck Assayed Chemistry Control device:

Important Note: The provided document is a 510(k) summary for an Assayed Quality Control Material. This type of device is used to monitor the performance of laboratory tests, not to perform diagnostic tests directly on patients. Therefore, the "acceptance criteria" and "study" described are centered around the performance of the control material (its stability and value assignment) and its equivalence to a predicate control device, rather than the diagnostic accuracy or clinical utility of a medical device that generates results on patient samples. Many of the requested categories in your prompt (e.g., number of experts, adjudication, MRMC studies, standalone performance, training set) are typically relevant for AI/imaging diagnostic devices and are not applicable to the type of device described here.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion	Acceptance Criteria (Implied from testing methods)	Reported Device Performance
Value Assignment	Lot-to-lot variation determined by testing new lot vs. previous lot, normalized to a serum standard (NIST or OEM). Target values within a defined range.	Target values are obtained by testing 16 replicates (4 replicates over 4 days). The average of these 16 data points is the mean. The range is determined by multiplying the mean by ± 20%. All testing is performed alongside Original Equipment Manufacturer (OEM) material to verify values before accepting new ranges.
Shelf Life Stability	Supports a 2-year shelf life when stored at 2-8°C.	Accelerated (high temperature) stress test was conducted, and results support a 2-year shelf life when stored at 2-8°C.
Reconstituted Stability	Stable for up to 20 days at -20°C (frozen).	Testing showed reconstituted controls are stable for up to 20 days at -20°C.
In-use Stability (Refrigerated)	Stable for 7 days when stored at 2-8°C, with specific exceptions.	Values are stable for 7 days when stored at 2-8°C (tightly capped) with the following exceptions: Acid Phosphatase will be stable for 3 days, AST for 1 day, CK, LDH, T4 free and TSH for 6 days. (Note: The document implies these specific stabilities meet the acceptance criteria for those analytes).
Material Safety (Human Source)	Found negative for specific infectious agents.	All human source material was tested and found negative by FDA approved methods for HBsAg, HCV, and HIV-1/2.
Substantial Equivalence	Demonstrates substantial equivalence to the predicate device in composition, intended use, packaging, storage, and shelf life.	The conclusion states that based on the submitted results, the device "claims substantial equivalence to the predicate device in Composition... Intended use, Packaging, Storage, and Shelf life." This implies that the performance in the aforementioned areas was found to be comparable or equivalent to the predicate, as required for 510(k) clearance.

Study Description:

The study proving the device meets the acceptance criteria is primarily an internal validation study and comparative analysis against a predicate device and known standards.

The key aspects of the study include:

Value Assignment Study: This involves preparing a new lot of the control material and characterizing its analyte concentrations.
- Methodology: 16 replicates (4 replicates each over 4 days) are tested. The mean of these 16 data points establishes the target mean value. A range of ±20% of the mean defines the acceptable limits for control performance.
- Comparative Element: Testing is performed alongside OEM material to verify values. Lot-to-lot variation is determined by comparing the new lot to a previous lot, normalized to a serum standard (NIST or OEM).
Stability Studies: These evaluate how the control material performs under different storage conditions and over time.
- Shelf Life: An accelerated (high temperature) stress test was conducted to project and support the 2-year shelf life.
- Reconstituted Stability: Testing determined stability for 20 days when frozen at -20°C.
- In-use Stability: Testing determined stability for 7 days when refrigerated at 2-8°C, with specific shorter stabilities noted for certain analytes.
Safety Testing: All human source material was tested for infectious agents (HBsAg, HCV, HIV-1/2) using FDA-approved methods.
Comparison to Predicate Device: A detailed comparison was made between the new device and the predicate device (K103364) across various attributes like name, 510(k) number, intended use, matrix, form, levels, storage, reconstituted stability, shelf life, and packaging. The key difference was the expanded list of analytes the new device is assayed for, indicating the device meets the performance for these additional analytes.

2. Sample Size used for the test set and the data provenance:

Sample Size for Value Assignment (Test Set): 16 replicates were used for each analyte to establish the mean and range for value assignment.
Data Provenance: The data is generated internally by Diamond Diagnostics, Inc., as part of their manufacturing and quality control processes. The document does not specify the country of origin for the data, but the company is located in Holliston, MA, USA, and the submission is to the FDA, implying studies conform to US regulatory standards. The studies conducted are prospective for the specific lot being validated.

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

This question is not applicable to this type of device. The "ground truth" for a quality control material is established through precise analytical measurements using calibrated instruments and reference materials (like NIST standards) or comparison to existing validated OEM materials. It does not involve human expert interpretation in the way that, for example, a diagnostic imaging device would.

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

Not applicable. As described above, the "truth" for this control material is based on analytical measurements, not subjective human judgment requiring adjudication.

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-powered diagnostic device involving human readers or interpretation of clinical cases.

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

Not applicable. This is not an algorithm or AI-based device. Its "performance" is its intrinsic analytical characteristics and stability, which are measured directly.

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

The "ground truth" for the control material's analyte concentrations is established by:

Analytical Measurement: Precise quantitative measurement of analytes using laboratory instrumentation.
Reference Materials: Normalization to NIST (National Institute of Standards and Technology) comparable standards or Original Equipment Manufacturer (OEM) materials.
Comparison to Predicate/Previous Lots: Ensuring consistency and comparability with previously validated lots and the predicate device.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context. The "value assignment" process involves establishing the characteristics of each new lot, which is analogous to a validation step for that specific lot, rather than training a model.

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

Not applicable, as there is no "training set" for this device.

Summary

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·5. 510(k) Summary

510(k) Number:	K124009	APR 1 7 2013
Applicant:	Diamond Diagnostics, Inc.333 Fiske StreetHolliston, MA 01746
Contact Person:	Kathy CruzQuality Assurance ManagerPhone: (508) 429-0450 ext. 351Fax: (508) 429-0452
Date Prepared:	April 17, 2013
Classification Name:	Assayed Quality Control Material
Trade Name:	Mission CliniCheck Assayed Chemistry Control
Device Classification: 21 CFR 862.1660
Device Class:	Class I (Reserved)
Classification Panel:	Clinical Chemistry
Product Code:	JJY
Intended Use:	Mission CliniCheck Controls is intended for use as an assayed quality control serumto monitor the precision of laboratory testing procedures for the following analytes,Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT),Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein,Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1(APO-A1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin(Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2),Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine,Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, ImmunoglobulinA (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-BindingCapacity, Total (TIBC), Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lacticacid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus,Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total,Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea, Urea Nitrogen,and Uric Acid on instruments listed in the expected values chart.

な

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Device Description: Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C.

All human source material was tested and found negative by FDA approved methods for HBsAg, HCV, and HIV-1/2.

Value Assignment: Mission CliniCheck Assayed Chemistry Control value assignment is lot specific. Lot to lot variation is determined by testing new lot vs. previous lot normalized to either a serum standard made with corresponding analyte NIST or Original Equipment Manufacturer (OEM). The target values are obtained by testing 16 replicates, 4 replicates each over a period of 4 days. The average of these 16 data points is the mean. The range is then determined by multiplying the mean by ± 20%, creating the upper and lower range. All testing is performed alongside (OEM) Original Equipment Manufacturer material to verify values before accepting new ranges.

Mission CliniCheck Assayed Chemistry Control, Levels 1 and 2 Predicate Device:

Predicate 510(k): K103364

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Comparison with Predicate Device:

Product	New Device	Predicate
Name	Mission CliniCheck Assayed Chemistry	Same
	Control
510(k)	K124009	K103364
PN	DD-93001D, DD-93002D	Same
Intended Use	For in vitro diagnostic use as an assayedquality control serum to monitor the precisionof laboratory testing procedures for thefollowing analytes, Acetaminophen, AcidPhosphatase (Total), AlanineAminotransferase (ALT/GPT), Albumin,Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, AlphaHydroxybutyrate Dehydrogenase (α-HBDH),Amylase, Apolipoprotein A-1 (APO-A1),Aspartate Aminotransferase (AST/GOT),Bilirubin (Direct), Bilirubin (Total), C3Complement, C4 Complement, Calcium,Carbon Dioxide (CO2), CarcinoembryonicAntigen (CEA), Ceruloplasmin, Chloride,Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase(CK), Creatinine, Digoxin, GammaGlutamyltransferase (GGT), Glucose,Haptoglobin, Immunoglobulin A (IgA),Immunoglobulin G (IgG), Immunoglobulin M(IgM), Iron, Iron-Binding Capacity, Total(TIBC), Iron Binding Capacity, Unsaturated(UIBC), Lactate (Lactic acid), LactateDehydrogenase (LDH), Lipase, Lithium,Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total,T4 Free, T4 Total, Thyroid Stimulating	Not assayed for Acetaminophen,Alpha-1 Anti-Trypsin, AlphaFetoprotein, CarcinoembryonicAntigen, Ceruloplasmin, Digoxin,Haptoglobin
	Hormone (TSH), Transferrin, Triglycerides,Urea, Urea Nitrogen, and Uric Acid on
	instruments listed in the expected values
	chart.
Matrix	Serum	Same
Form	Lyophilized	Same
Levels	Two	Same
Storage	2-8°C	Same
Reconstituted	20 days at -20°C	Same
Stability	Same	Same
Shelf Life	24 months	Same
Packaging	12 x 5 mL	Same

Stability

Tests were conducted to determine stability. Accelerated (high temperature) stress test was done and results support a 2 year shelf life when the controls are stored at 2-8°C. Testing showed that reconstituted Mission CliniCheck Assayed Chemistry Controls are stable for up to 20 days at -20°C. Once thawed, the controls cannot be refrozen and must be discarded. Values are also stable for 7 days when stored at 2-8℃ with the following exception: Acid Phosphatase will be stable for 3 days, AST for 1 day, CK, LDH, T4 free and TSH for 6 days when stored tightly capped at 2-8℃.

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Conclusion:

Based on the results submitted in this pre market notification CliniCheck Assayed Chemistry Control claims substantial equivalence to the predicate device in Composition, that is Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1 (APO-A1), Aspartale Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-Binding Capacity, Total (TIBC), Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea Nitrogen, and Uric Acid, Intended use, Packaging, Storage, and Shelf life

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three horizontal bars representing the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2013

Diamond Diagnostics, Inc. C/O Kathy Cruz 333 Fiske St HOLLISTON MA 01746

Re: K124009

Trade/Device Name: Mission CliniCheck Assayed Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJY Dated: March 20, 2013 Received: April 04, 2013

Dear Ms. Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be , found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for

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Page 2-Ms. Cruz

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K124009

Device Name: Mission CliniCheck Assayed Chemistry Control

Indications for Use:

Prescription Use
(21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use
(21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W.Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K124009

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.