← Product Code [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW) · K070391

# ELECSYS PTH TEST SYSTEM (K070391)

_Roche Diagnostics Corp. · CEW · Mar 20, 2007 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K070391

## Device Facts

- **Applicant:** Roche Diagnostics Corp.
- **Product Code:** [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW.md)
- **Decision Date:** Mar 20, 2007
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1545
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Elecsys PTH assay is an in vitro immunoassay for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on Roche Elecsys and cobas e analyzers.

## Device Story

Elecsys PTH test system; immunoassay for quantitative intact PTH measurement in human serum/plasma. Modification: separation of 9-minute (Elecsys PTH STAT) and 18-minute (Elecsys PTH) application kits; expansion of 9-minute application to Elecsys 2010 and cobas e411 analyzers; reduction of hemoglobin interference limit from 1.5 g/dL to 0.25 g/dL. Used in clinical laboratory settings by trained technicians. Output: quantitative PTH concentration. Clinical decision-making: aids diagnosis/monitoring of parathyroid disorders. Benefit: faster turnaround time for STAT applications.

## Clinical Evidence

Bench testing only. Design control activities, including FMEA and verification/validation testing, were performed to assess the impact of modifications (packaging, analyzer compatibility, and interference limit changes).

## Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; biotinylated capture antibody; ruthenium-labeled detection antibody. Analyzers: Elecsys 1010, 2010, cobas e 411, E170, cobas e 601. Sample: human serum/plasma (K3-EDTA). Calibration: 2-point calibration with master curve via reagent barcode.

## Regulatory Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

## Predicate Devices

- Roche Elecsys PTH test system and Elecsys PTH CalSet ([K992680](/device/K992680.md))

## Submission Summary (Full Text)

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PECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER K070391

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k992680 –Roche Elecsys PTH test system and Elecsys PTH CalSet.

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A. Separate the 9 minute and 18 minute applications into their own distinct packaging configurations. 9 minute application kit is called Elecsys PTH STAT and Elecsys PTH STAT CalSet. The 18 minute application kit will continue to be named Elecsys PTH and Elecsys PTH CalSet.

B. Apply 9 minute application to the Elecsys 2010 and cobas e411 analyzers.

C. Change in hemoglobin interference limit from 1.5 g/dL to 0.25 g/dL. Add limitations: Do not analyze samples that show visible signs of hemolysis.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. FMEA
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K070391](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K070391)

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