For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Device Description

The VITROS Chemistry Products Ca DT Slide assay is performed using the VITROS Chemistry Products Ca DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/ DT60 II Chemistry Systems. The VITROS Ca DT Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca DT slide. A drop of patient sample is deposited on the VITROS Ca DT Slide and is evenly distributed by the spreading layer to the underlying lavers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VITROS Chemistry Products Ca DT Slides.

Disclaimer: The provided document is a 510(k) summary for a diagnostic test system, not a typical document detailing AI/ML model performance. Therefore, many standard AI/ML study components (like expert ground truth, MRMC studies, training set details) are not applicable or explicitly mentioned in this type of submission. The analysis below extracts what is available and notes what is not.

Acceptance Criteria and Reported Device Performance

The document describes a modification to an existing device, the VITROS Chemistry Products Ca DT Slides, and asserts its substantial equivalence to the predicate device. The primary characteristics compared are:

Device Characteristic	New Device VITROS Chemistry Products Ca DT Slide (Modified)	Predicate Device VITROS Chemistry Products Ca DT Slide (Current)	Reported Performance (Implied Acceptance)
Intended Use	No Change	For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma.	The modified device maintains the same intended use. This implies performance must meet the requirements for this intended use.
Fundamental scientific technology	No Change	Dry, multilayered slide utilizing spectrophotometrics	The core technology and methodology remain unchanged, implying similar performance characteristics.
Test Type	No Change	Colorimetric	The colorimetric detection method is unchanged.
Reactive Ingredients per cm²	No Change	Arsenazo III dye 60 µg	The key reactive ingredient and its concentration are unchanged.
Sample type	No Change	Serum and plasma	The device continues to be validated for serum and plasma samples.
Instrumentation	No Change	VITROS DT60/DT60 II Chemistry Systems	The device is compatible with the same instrumentation, indicating no change in operational performance.
Composition of the Spreading Layer*	TiO2: New SupplierCellulose Acetate: New lotEstane: Increased to 1.7 times the current level (70% increase).	TiO2, Cellulose Acetate, Estane, Surfactants.	The document implies that despite changes in the spreading layer composition, the overall performance remains substantially equivalent. This is the primary area of modification and thus the focus for proving equivalence.
Manufacturing Process Changes*	Increased concentration of Estane raised viscosity, requiring modifications to solution delivery system and non-solvent flow rate.	Current Manufacturing Process.	Modifications were made to the manufacturing process to accommodate the higher Estane concentration, with the implication that these changes did not negatively impact performance.

Acceptance Criteria (Implicit from Substantial Equivalence): The fundamental acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device. This means the modified device must perform comparably to the previously cleared device, not introducing new questions of safety oreffectiveness. The "reported device performance" is essentially the claim of substantial equivalence, backed by data showing comparable analytical performance to the predicate.

Study Details (Based on an IVD 510(k) Submission)

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

Sample Size: "patient and quality control samples with measured calcium values spanning the assay range." (Page 3) No specific number of samples is given.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it evaluates the modified device's performance against historical or concurrent data from the predicate device. It is a performance verification rather than a prospective clinical trial.

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

This information is not applicable for this type of in vitro diagnostic device submission concerning analytical performance. The "ground truth" for a calcium assay is typically established through reference methods or the predicate device's measured values, not by human expert interpretation.

4. Adjudication method for the test set:

Not applicable. This pertains to expert consensus on interpretation, which is not relevant for a quantitative chemical assay.

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:

No. This is an in vitro diagnostic device for quantitative measurement, not an AI/ML-based diagnostic imaging or assessment tool. Therefore, MRMC studies and human reader improvement with AI are not relevant.

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

Yes, implicitly. The device is an automated, quantitative chemical assay. Its performance is measured independently of human interpretation of the result (though humans operate the instrument and interpret the final numerical value relative to clinical ranges). The "algorithm" here is the chemical reaction and spectrophotometric measurement, which operates in a standalone fashion.

7. The type of ground truth used:

The ground truth for this type of IVD device is the actual calcium concentration in the samples. This would be established by:
- Reference methods or highly characterized control materials.
- Agreement with the predicate device's measurements for comparison/equivalence.
- The "measured calcium values spanning the assay range" implies these are known or established concentrations against which the device's accuracy and precision are evaluated.

8. The sample size for the training set:

Not applicable in the context of AI/ML training sets. This device system, while involving some manufacturing process adjustments, is based on established chemical principles, not a machine learning model that undergoes a "training" phase with a dataset. The "training" in this context refers to the calibration of the instrument, for which the VITROS Chemistry Products DT Calibrator Kit is used. The calibrator kit contains "four levels of lyophilized standards." (Page 2)

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

For the calibrator kit (which serves a similar function to a training set in establishing the measurement curve), the ground truth (assigned values for each of the four levels) would be established by certified reference materials and/or traceability to international standards for calcium measurement. The document states they are "lyophilized standards" prepared from "bovine serum albumin and processed bovine serum," with "enzymes, electrolytes, stabilizers, preservatives and other organic analytes" added (Page 2).

Summary

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Summary Information

510(k) Summary

SEP 2 4 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K072443

Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, address, Rochester, New York 14626-5101 contact (585) 453-4041
Contact Person: Marlene A. Hanna
1. Preparation Date Special 510(k) prepared: August 29, 2007 date
1. Device Trade or Proprietary Name: name VITROS Chemistry Products Ca DT Slides Common Name: calcium test Classification Name: Calcium test system (21 CFR 862.1145)

VITROS Chemistry Products DT Calibrator Kit Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)

1. Predicate The VITROS Chemistry Products Ca DT Slides (modified) and VITROS Chemistry Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry device Products Ca DT Slides (current slide) and VITROS Chemistry Products DT Calibrator Kit. The FDA cleared the VITROS Chemistry Products Ca DT Slides on May 12, 1987 (K870035) under the product name KODAK EKTACHEM DT SLIDES (Ca). With the purchase of KODAK Clinical Products Division by Johnson and Johnson in 1994, the product branding was revised to VITROS Chemistry Products Ca DT Slides The most recent FDA clearance for the VITROS Chemistry Products DT Calibrator Kit was May 25, 2007 (K071216).
  Continued on next page

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510(k) Summary, Continued

The VITROS Chemistry Products Ca DT Slide assay is performed using the VITROS 5. Device Description Chemistry Products Ca DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/ DT60 II Chemistry Systems. The VITROS Ca DT Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca DT slide. A drop of patient sample is deposited on the VITROS Ca DT Slide and is evenly distributed by the spreading layer to the underlying lavers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products. 6. Device VITROS Chemistry Products Ca DT Slides intended For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure use calcium (Ca) concentration in serum and plasma. VITROS Chemistry Products DT Calibrator Kit For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NHz, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Continued on next page

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510(k) Summary, Continued

1. Comparison The VITROS Chemistry Products Ca DT Slide (modified) and VITROS Chemistry Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry Products to predicate Ca DT Slide and VITROS Chemistry Products DT Calibrator Kit, which were Cleared device by the FDA for in vitro diagnostic use.
  VITROS Chemistry Products Ca DT Slide: (K870035, cleared May 12, 1987) VITROS Chemistry Products DT Calibrator Kit: (K071216, cleared May 25, 2007).

Table 1 lists the characteristics of the tests performed using the VITROS Ca DT Slide (modified) and the VITROS Ca DT Slide (current).

Table 1. List of VITROS Chemistry Products Ca DT Slide Characteristics: Comparison to Predicate Device

DeviceCharacteristic	New DeviceVITROS Chemistry Products Ca DT Slide(Modified)	Predicate DeviceVITROS Chemistry Products Ca DT Slide(Current)
Intended Use	No Change.	For in vitro diagnostic use only.VITROS Ca DT Slides quantitatively measurecalcium (Ca) concentration in serum and plasma.
Fundamentalscientifictechnology	No Change.	Dry, multilayered slide utilizingspectrophotometrics
Test Type	No Change.	Colorimetric
ReactiveIngredients percm2	No Change.	Arsenazo III dye 60 µg
Sample type	No Change.	Serum and plasma
Instrumentation	No Change.	VITROS DTSC/ DTSC II Analyzers
Composition of theSpreading Layer*component of theVITROS Ca Slide	TiO2: New SupplierCellulose Acetate: New lotEstane: Increased to 1.7 times the current level, i.e.70% increase. Estane concentration is correlated tomanufacturability of the VITROS Ca Slide.Surfactants: No Change.	TiO2, Cellulose Acetate, Estane, Surfactants.
ManufacturingProcess Changesdue to theincreased Estanelevel in theSpreading* LayerComponent of theVITROS Ca Slide	The increased concentration of Estane raised theviscosity, requiring modifications to the solutiondelivery system and to the non-solvent flow rate.	Current Manufacturing Process.

*The "Spreading Layer" refers to the spreading layer component of the VITROS Chemistry Products Ca DT Slide (Refer to Page 2 of the Instructions For Use for VITROS Chemistry Products Ca DT Slides). The Spreading Layer evenly distributes sample fluid to the underlying layers of the VITROS Ca DT Slide.

No modifications were made to VITROS Chemistry Products DT Calibrator Kit.

Continued on next page

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510(k) Summary, Continued

The information presented in the premarket notification demonstrates that the 8. Conclusions performance of the VITROS Chemistry Products Ca DT Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured calcium values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products Ca DT Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.

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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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above three wavy lines, which could represent water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 4 2007

Ortho-Clinical Diagnostics, Inc. c/o Marlene A. Hanna 100 Indigo Creek Drive Rochester, New York 14626-5101

Re: K072443

Trade/Device Name: VITROS Chemistry Products Ca DT Slides VITROS Chemistry Products DT Calibrator Kit Regulation Number: 21 CFR& 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY, JIX Dated: August 29, 2007 Received: August 30, 2007

Dear Ms. Hanna:

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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K072443

Device Name: VITROS Chemistry Products Ca DT Slides

Indication For Use: For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Prescription Use _ X (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 Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072443

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Indication for Use

510(k) Number (if known):

K072443

Device Name: VITROS Chemistry Products DT Calibrator Kit

Indication For Use: For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Prescription Use X (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 Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072443

Page 2 of 2

Ortho-Clinical Diagnostics VITROS Chemistry Products Ca DT Slides VITROS Chemistry Products DT Calibrator Kit

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.