The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of there main elements: The VITROS Immunodiagnostic Products range of immunoassay products in this case VITROS Immunodiagnostic Products Cortisol Reagent Pack, VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990) and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990), which are combined by the VITROS Immunodiagnostic System to perform the VITROS Cortisol assay. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the VITROS Immunodiagnostic Products Cortisol Assay. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the following information cannot be fully extracted or is not explicitly stated in the document:

A table of acceptance criteria and the reported device performance: The document only provides a comparison of device characteristics between the new and predicate devices (Table 1) and a general statement of "equivalent performance." It does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or detailed performance data against those criteria.
Sample sized used for the test set and the data provenance: The document states that "testing human samples throughout the assay range" was done, but does not provide specific sample sizes for test sets, data provenance (e.g., country of origin), or whether the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is an in vitro diagnostic device, not an image-based AI system that would involve human readers. Therefore, an MRMC study is not applicable or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an immunoassay system, not an algorithm in the context of AI. Its performance is inherent in its design and operation.
The type of ground truth used: The document mentions "manufactured reagents, positive and negative controls and testing human samples." For an immunoassay, the 'ground truth' would typically be established by reference methods or validated clinical diagnoses/outcomes, but this is not explicitly detailed.
The sample size for the training set: Not applicable in the context of an immunoassay for which no separate "training set" is described for an algorithm.
How the ground truth for the training set was established: Not applicable.

Here's what can be extracted based on the provided text, focusing on the comparison to the predicate device and the general statement of performance:

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

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, precision, bias thresholds). Instead, "equivalent performance" to the predicate device is the overarching acceptance criterion for the 510(k) submission.

Device Characteristic	Predicate Device (K983990-Current)	New Device (Modified)	Note on Performance
Reportable Range	0 to 1700 nmol/L	4.39 to 1700 nmol/L	The new device has a slightly different lower limit for its reportable range, starting at 4.39 nmol/L compared to 0 nmol/L for the predicate. The document implies that performance within this modified range is equivalent.
Sample type	Serum, plasma (EDTA or heparin) or urine.	Serum plasma (EDTA or heparin) or urine.	No change. Performance is implied to be equivalent across these sample types.
Biotinylated Antibody Reagent	Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of two bleeds from a single sheep immunized in-house at Pollards Wood). Concentration: 1.5 mg/Kg	Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of eight bleeds from two sheep immunized in-house at Pollards Wood). Concentration: 0.5 mg/Kg	Antibody source and concentration changed. The submission declares that "Equivalent performance was demonstrated using manufactured reagents... and testing human samples".
HRP Conjugate Reagent	Contains Bovine Alpha Globulin	Removed Bovine Alpha Globulin. Added ANS (8-anilino-1-napthalenesulfonic acid) to correct for azide.	Reagent composition changed. The submission declares that "Equivalent performance was demonstrated using manufactured reagents... and testing human samples".
Basic principle	Solid phase immunoassay	Solid phase immunoassay	No change.
Tracer	Enzyme labeled	Enzyme labeled	No change.
Instrumentation	VITROS Immunodiagnostic System	VITROS Immunodiagnostic System	No change.
Sample volume	25µL	25µL	No change.
Incubation time and temperature	30 minutes at 37°C	30 minutes at 37°C	No change.

Study Proving Acceptance Criteria:

The study described is a comparison study demonstrating substantial equivalence of the modified VITROS Immunodiagnostic Products Cortisol Assay to the previously cleared predicate device (K983990). The conclusion states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples throughout the assay range."

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: Not explicitly stated. The document only mentions "testing human samples throughout the assay range."
Data Provenance: Not specified (e.g., country of origin not mentioned).
Retrospective or Prospective: Not specified.

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 as this is not an image-based diagnostic or expert interpretation study. The 'ground truth' for an immunoassay's performance would typically refer to the true concentration of cortisol in samples, usually determined by reference methods or clinical gold standards. The document does not detail how this ground truth was established for the "human samples."

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

Not applicable for this type of immunoassay study.

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, not an AI system.

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

The device itself is a standalone immunoassay system. The performance evaluated is the direct output of the system. There is no concept of an "algorithm only" in the context of human-in-the-loop for this device.

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

The document implies that performance was assessed against "manufactured reagents, positive and negative controls and testing human samples." For human samples, the ground truth for cortisol levels would typically come from a well-established reference assay or a clinically validated method, but this is not explicitly detailed.

8. The sample size for the training set

Not applicable. This is an immunoassay, not a machine learning algorithm requiring a distinct "training set."

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

Not applicable.

Summary

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Ortho-Clinical Diagnostics

a fohnson fohnson company

100 Indigo Creek Drive

Coster, New York 4

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: Ko60480

Submitter Name, Address and Contact 1

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-4131

Leah Van De Water Contact Person:

2 Preparation Date

Date 510(k) prepared: February 22, 2006

3 Device Name

VITROS Immunodiagnostic Products Cortisol Reagent Pack Common Name: Cortisol Reagent Pack Classification Name: Cortisol(Hydrocortisone and Hydroxycorticosterone) Test System (862.1205), Class II
VITROS Immunodiagnostic Products Cortisol Calibrators Common Name: Cortisol Calibrators Classification Name: Calibrator (862.1150), Class II
VITROS Immunodiagnostic Products NT-proBNP Metabolism Controls Common Name: Metabolism Controls Classification: Quality control material (862.1660), Class I

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4 Predicate Device

The VITROS Immunodiagnostic Products Cortisol Assay is substantially equivalent to the VITROS Immunodiagnostic Products Cortisol Assay (K983990-original formulation). The only modifications made to the proposed VITROS Immunodiagnostic Products Cortisol Assay are to the VITROS Immunodiagnostic Products Cortisol Reagent Pack. There are no modifications being made to the VITROS Immunodiagnostic Products Cortisol Calibrators or the VITROS Immunodiagnostic Products Metabolism Controls, which were previously cleared under K983990.

5 Device Description

The system is comprised of there main elements:

The VITROS Immunodiagnostic Products range of immunoassay . products in this case VITROS Immunodiagnostic Products Cortisol Reagent Pack, VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990) and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990), which are combined by the VITROS Immunodiagnostic System to perform the VITROS Cortisol assay.
. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

6 Device Intended Use

VITROS Immunodiagnostic Cortisol Reagent Pack

For the in vitro quantitative measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

VITROS Immunodiagnostic Products Cortisol Calibrators

For the in vitro use in the calibration of the VITROS Immunodiagnsotic System for the quantitative measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

VITROS Immunodiagnostic Products Metabolism Controls

For the in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

7 Comparison to Predicate Device

The VITROS Immunodiagnostic Products Cortisol Reagent Pack is substantially equivalent to VITROS Immunodiagnostic Products Cortisol Reagent Pack (K983990) cleared by the FDA for in vitro diagnostic use.

Table 1 lists the characteristics of the VITROS Cortisol Reagent Pack (new formulation) and the VITROS Cortisol Reagent Pack (K983990original formulation). There are no modifications to the current VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990), and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990).

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DeviceCharacteristic	Predicate DeviceVITROS Cortisol ReagentPack(K983990-Current)	New DeviceVITROS Cortisol ReagentPack(Modified)
Reportable Range	0 to 1700 nmol/L	4.39 to 1700 nmol/L
Sample type	Serum, plasma (EDTA or heparin) or urine.	Serum plasma (EDTA or heparin) or urine.
Biotinylated AntibodyReagent	AntibodySheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of two bleeds from a single sheep immunized in-house at Pollards Wood)	AntibodySheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of eight bleeds from two sheep immunized in-house at Pollards Wood)
	Concentration of Antibody1.5 mg/Kg	Concentration of Antibody0.5 mg/Kg
HRP Conjugate Reagent	Contains Bovine AlphaGlobulin	Removed Bovine AlphaGlobulinAdded ANS (8-anilino-1-napthalenesulfonic acid) tocorrect for azide
Basic principle	Solid phase immunoassay	Solid phase immunoassay
Tracer	Enzyme labeled	Enzyme labeled
Instrumentation	VITROS ImmunodiagnosticSystem	VITROS ImmunodiagnosticSystem
Sample volume	25µL	25µL
Incubation time andtemperature	30 minutes at 37°C	30 minutes at 37°C

Table 1 List of VITROS Cortisol Reagent Pack Characteristics: Comparison to Predicate Device

10 Conclusions

The information presented in the pre-market notification demonstrates that the performance of the proposed VITROS Immunodiagnostic Products Cortisol Assay is substantially equivalent to the cleared predicate device.

Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples throughout the assay range.

The information presented in the premarket notification provides a reasonable assurance that the proposed VITROS Cortisol Assay is safe and effective for the stated intended use.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and has its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Leah Van De Water Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Dr. Rochester, NY 14626-5101

Re: K060480

Trade/Device Name: VITROS Immunodiagnostic Products Cortisol Reagent Pak VITROS Immunodiagnostic Products Cortisol Calibrator VITROS Immunodiagnostic Products Metabolism Controls Regulation Number: 21 CFR§862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: CGR, JIS, JJX Dated: June 16, 2006 Received: June 19, 2006

JUL - 3 2006

Dear Ms. Water:

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 Amendmants, 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, into rece 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 Party 820).

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Page 2 -

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) 276-0484. 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 the momber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Albert
Albert S.
Ph.D.

Alberto Gutierrez, Ph.D. 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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ATTACHMENT B

Indications for Use

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):

Device Name:

VITROS Immunodiagnostic Products Cortisol Reagent Pack VITROS Immunodiagnostic Products Cortisol Calibrator VITROS Immunodiagnostic Products Metabolism Controls

Indications for Use:

The measurement of cortisol in human serum, plasma (heparin or EDTA) or urine aids in the assessment of adrenal status.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page | of |

C.A.C.
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

L060470

Regulation Number and Section

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.