Elecsys Progesterone III Cal Check 5

K150955 · Roche Diagnostics · JJX · May 1, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150955
• Device Name: Elecsys Progesterone III Cal Check 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Progesterone III CalCheck 5 is a lyophilized, multi-level assayed control consisting of plant-derived progesterone in a human serum matrix. It is used in clinical laboratories to verify calibration and assay range for the Elecsys Progesterone III reagent on Roche Elecsys and cobas e immunoassay analyzers. The device is reconstituted with distilled or deionized water by laboratory personnel. The healthcare provider uses the recovered values of the CalCheck to ensure the immunoassay analyzer is performing within established specifications. This verification process helps maintain the accuracy and reliability of patient progesterone test results, supporting clinical decision-making in endocrine testing.

Clinical Evidence

Bench testing only. Stability studies (open-vial and accelerated) were conducted on the cobas e 411 analyzer. Open-vial stability confirmed 4-hour stability at 20-25°C. Accelerated stability (35°C for 3 weeks) supported an 18-month shelf-life at 2-8°C. Value assignment was performed in duplicate on at least three cobas e 601 analyzers, with acceptance criteria met for mean recovery.

Technological Characteristics

Lyophilized human serum matrix containing plant-derived progesterone. Traceable to ID-GC/MS (isotope dilution gas chromatography mass spectrometry) analogous to BCR-348R and ERM-DA347. Five levels provided. Reconstitution required with 1.0 mL distilled/deionized water. Compatible with MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Progesterone III reagent on Elecsys and cobas e immunoassay analyzers. No specific patient population is described as this is a laboratory control product.

Regulatory Classification

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.

Submission Summary (Full Text)

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May 1, 2015

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

ROCHE DIAGNOSTICS ADAM CLARK REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250

Re: K150955

Trade/Device Name: Elecsys Progesterone III CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: April 8, 2015 Received: April 9, 2015

Dear Mr. Clark:

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 Parts 801 and 809); 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.

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Page 2-Mr. Clark

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Katherine Serrano -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) K150955

Device Name Elecsys Progesterone III CalCheck 5

Indications for Use (Describe)

The Elecsys Progesterone III CalCheck 5 is an assayed control for use in callbration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: normal;"> <span style="font-style: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> <span style="white-space: nowrap;"> <span style="word-spacing: 0px;"> <span style="letter-spacing: normal;"> <span style="text-transform: none;"> <span style="direction: ltr;"> <span style="unicode-bidi: embed;"> <span style="display: inline-block; width: 12px; height: 12px; border: 1px solid black; text-align: center; vertical-align: middle; line-height: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: normal;"> <span style="font-style: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> <span style="white-space: nowrap;"> <span style="word-spacing: 0px;"> <span style="letter-spacing: normal;"> <span style="text-transform: none;"> <span style="direction: ltr;"> <span style="unicode-bidi: embed;"> <span style="display: inline-block; width: 12px; height: 12px; border: 1px solid black; text-align: center; vertical-align: middle; line-height: 10px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> |

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# 510(k) Summary for the Elecsys Progesterone III CalCheck 5

| Introduction | According to the requirements of 21 CFR 807.92, the following information provide<br>sufficient detail to understand the basis for a determination of substantial<br>equivalence. | | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--|
| Submitter<br>Name,<br>Address,<br>Contact | Roche Diagnostics<br>9115 Hague Road<br>P.O. Box 50416<br>Indianapolis, IN 46250-0415<br><br>Contact Person: Adam Clark<br>Phone: [phone] Fax: [phone] Email: [e-mail] Secondary Contact Person: Michael Leuther<br>Phone: [phone] Fax: [phone] Email: [e-mail] Date Prepared: April 27, 2015 | | |
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official<br>notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics<br>Act of our intention to market the device described in this Premarket Notification<br>510(k).<br>The purpose of this premarket notification is to obtain FDA review and clearance for<br>the Elecsys Progesterone III CalCheck 5. | | |
| Device Name | Proprietary name: | Elecsys Progesterone III CalCheck 5 | |
| | Common name: | Progesterone III CalCheck 5 | |
| | Classification name: | 21 CFR 816.1660, Single (specified) analyte controls (assayed<br>and unassayed) | |
| | Product Code: | JJX | |
| | Predicate Device: | Elecsys Estradiol III CalCheck 5 | |

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#### Establishment For the Elecsys Progesterone III CalCheck 5, the establishment registration number Registration for Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg, Germany is 9610529. The establishment registration number for Roche Diagnostics in the United States is 1823260.

Classification The FDA has classified the Elecsys Progesterone III CalCheck 5 as a Class I reserved device.

| Panel | Product Code | Classification Name | Regulation Citation |
|-------------------------|--------------|-------------------------------------------------------------|---------------------|
| Clinical Chemistry (75) | JJX | Single (specified) analyte controls (assayed and unassayed) | 21 CFR 862.1660 |

Device Description Elecsys Progesterone III CalCheck 5:

- The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels of plant-derived Progesterone in a human serum matrix. It is traceable via ID-GC/MS (isotope dilution gas chromatography mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347.

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| Intended Use/<br>Indications<br>for Use | The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration<br>verification and for use in the verification of the assay range established by the<br>Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay<br>analyzers. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The Elecsys Progesterone III CalCheck 5 is substantially equivalent to other products<br>in commercial distribution intended for similar use. We claim equivalency to the<br>currently approved Elecsys Estradiol III CalCheck 5 (k142147). | |
| Substantial<br>Equivalence -<br>Comparison | The table below compares Elecsys Progesterone III CalCheck 5 with the predicate<br>device, Elecsys Estradiol III CalCheck 5 (k142147). | |
| Assay Comparison | | |
| Feature | Predicate Device:<br>Elecsys Estradiol III CalCheck 5<br>(k142147) | Candidate Device:<br>Elecsys Progesterone III CalCheck 5 |
| General Assay Features | | |
| Intended Use/<br>Indications for<br>Use | The Elecsys Estradiol III<br>CalCheck 5 is an assayed control<br>for use in calibration verification<br>and for use in the verification of<br>the assay range established by the<br>Elecsys Estradiol III reagent on<br>the indicated Elecsys and cobas e<br>immunoassay analyzers. | The Elecsys Progesterone III CalCheck 5<br>is an assayed control for use in<br>calibration verification and for use in the<br>verification of the assay range<br>established by the Elecsys Progesterone<br>III reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. |
| Analyte | Estradiol (Synthetic) | Progesterone (plant material) |
| Matrix | Human serum matrix | Human serum matrix |
| Levels | Five | Five |
| Assay Measuring<br>Range | 5 - 3000 pg/mL | 0.05 - 60 ng/mL |
| Check Target<br>Values | Check 1: ≤ 10 pg/mL<br>Check 2: 100 pg/mL<br>Check 3: 1500 pg/mL<br>Check 4: 2400 pg/mL<br>Check 5: 3000 pg/mL | Check 1: ≤0.15 ng/mL<br>Check 2: 2.0 ng/mL<br>Check 3: 30.0 ng/mL<br>Check 4: 45.0 ng/mL<br>Check 5: 60.0 ng/mL |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1, Check 2,<br>Check 3, Check 4, and Check 5<br>with exactly 1.0mL distilled or<br>deionized water. Allow to stand<br>closed for 15 minutes, then mix<br>gently by inversion to ensure<br>homogeneity. | Reconstitute Check 1, Check 2, Check 3,<br>Check 4, and Check 5 with exactly<br>1.0mL distilled or deionized water.<br>Allow to stand closed for 15 minutes,<br>then mix gently by inversion to ensure<br>homogeneity. |
| Stability | Unopened:<br>Store at 2-8°C until<br>expiration dateOpened:<br>20-25°C: 4 hours | Unopened:<br>Store at 2-8°C until expiration<br>dateOpened:<br>20-25°C: 4 hours |
| Traceability | The Elecsys Progesterone III CalCheck 5 was standardized against ID-GC/MS<br>(isotope dilution gas chromatography mass spectrometry). | |
| Value<br>Assignment | Value assignment testing was conducted and passed pre-defined acceptance<br>criteria. For each Elecsys Progesterone III CalCheck 5 lot manufactured, the<br>CalChecks are run in duplicate on at least three <b>cobas e 601</b> analyzers. The assigned<br>value of each CalCheck is defined as the mean value obtained over at least 6<br>determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. | |
| | The CalCheck assigned range is calculated as ±27% of the assigned value<br>for levels 2 through 5. The label states that each laboratory should establish<br>appropriate acceptance criteria when using this product for its intended use. | |
| | The same value assignment procedure is performed on the <b>cobas e 411</b> . The<br>assigned values obtained are compared to those obtained on the <b>cobas e 601</b> . The<br>mean value obtained on the additional analyzer must be within 10% of the master<br>platform assigned value. After this acceptance criterion is met, the assigned values<br>from the master platform are deemed valid for the MODULAR ANALYTICS E170,<br><b>cobas e 411</b> , <b>cobas e 601</b> , and <b>cobas e 602</b> immunoassay analyzers. | |
| Target Values | The CalCheck target values for the Elecsys Progesterone III Calcheck 5 are as<br>follows: | |
| | Check Target Values | Check 1: ≤ 0.15 ng/mL |
| | | Check 2: 2.0 ng/mL |
| | | Check 3: 30.0 ng/mL |
| | | Check 4: 45.0 ng/mL |
| | | Check 5: 60.0 ng/mL |
| | Continued on next page | |

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Comparison of Elecsys Progesterone III CalCheck 5 with the predicate device, Elecsys Estradiol III CalCheck 5 (k142147). Table 1

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Stability Studies

Two studies were performed in order to verify the stability claims for the Progesterone III CalCheck 5. Additionally, a real-time stability study is ongoing to support the shelf-life stability claim.

Opened-vial and accelerated stability studies were completed on the cobas e 411. Because these studies are not analyzer-dependent, these results, in addition to realtime stability study results, can be applied to the MODULAR ANALYTICS E170, cobas e 601 and cobas e 602.

### Study 1. Open-Vial Stability:

The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 5 hours at 25℃ (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The on-test recovery was calculated as a percent of the reference value.

One Progesterone III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 was < 0.15 ng/mL. for CalCheck Level 2 85-115% and for level 3-5 90-110% recovery of the reference material value. The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C.

The CalCheck products are not stored on-board the analyzer, therefore no on-board stability claims are made.

### Study 2. Accelerated Stability:

The on-test material was stored lyophilized (as supplied to the user) at 35℃ for 3 weeks. The reference material was a freshly reconstituted set of CalChecks (stored at 2-8℃). After 3 weeks, the test and reference materials were tested in duplicate. The on-test recovery was calculated as a percent of the reference value.

One Progesterone III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 was ≤ 0.15 ng/mL, for CalCheck Level 2 85-115% and for level 3-5 90-110% recovery of the reference material value.

The accelerated stability model employed supports an initial shelf-life claim of 18 months when the Progesterone III CalCheck 5 are stored under normal storage conditions of 2-8°C.

We trust that the information provided in this Premarket Notification (510(k)) will Conclusion support a determination of substantial equivalence for the Elecsys Progesterone III Calcheck 5.