Who is the manufacturer of ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY?

Roche Diagnostics Corp. filed the 510(k) submission for ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706).

What is the FDA product code for ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY?

JMM. It is classified under 21 CFR 862.1400 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

K993706 · Roche Diagnostics Corp. · JMM · Jul 24, 2000 · Clinical Chemistry

Device Facts

Record ID	K993706
Device Name	ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
Applicant	Roche Diagnostics Corp.
Product Code	JMM · Clinical Chemistry
Decision Date	Jul 24, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1400
Device Class	Class 1

Intended Use

Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma.

Device Story

The ELECSYS β-CrossLaps/serum Immunoassay is an in vitro diagnostic test used on Roche ELECSYS 1010 and 2010 analyzers. It utilizes a two-step sandwich immunoassay principle with streptavidin-coated microparticles and electrochemiluminescence detection to quantify type I collagen degradation products in human serum or plasma. The device uses two monoclonal antibodies specific to the EKAHD-β-GGR amino-acid sequence. Results are calculated via a calibration curve generated by a 2-point calibration and a master curve provided by a reagent bar code card. The test is performed in a clinical laboratory setting by trained personnel. By measuring bone resorption markers, the device assists clinicians in monitoring the efficacy of anti-resorptive therapies in postmenopausal women and patients with osteopenia, potentially guiding treatment adjustments to improve patient bone health.

Clinical Evidence

Bench testing only. Performance characteristics compared to the predicate include within-run precision (4.6% to 1.0% CV across concentrations) and total precision (4.7% to 1.6% CV). Analytical sensitivity is 0.01 ng/mL. Interference testing showed no significant impact from bilirubin, hemoglobin, intralipid, biotin, or rheumatoid factor at specified concentrations. No clinical trial data on patient outcomes was required for this 510(k) clearance.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin microparticles; two monoclonal antibodies against EKAHD-β-GGR sequence. Automated operation on ELECSYS 1010/2010 analyzers. Measuring range 0.010–6.00 ng/mL. Traceable to internal reference standards (purified peptide).

Indications for Use

Indicated for assessing individual bone resorption and as an aid in monitoring anti-resorptive therapies (e.g., bisphosphonates, hormone replacement therapy) in postmenopausal women and individuals diagnosed with osteopenia.

Regulatory Classification

Identification

A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Predicate Devices

Osteometer Serum CrossLaps™ One Step ELISA (K990843)

Related Devices

K051297 — ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK · Roche Diagnostics Corp. · Sep 8, 2005
K990843 — SERUM CROSSLAPS ONE STEP ELISA · Osteometer Biotech A/S · Jul 9, 1999
K960171 — ACTIVE CROSSLAPS ELISA · Diagnostic Systems Laboratories, Inc. · Mar 28, 1996
K972788 — CROSSLAPS ELISA · Devices and Diagnostics Consulting Group · Dec 22, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ #### JUL 2 4 2000 #### 510(k) Summary # K 993706 According to the requirements of 21 CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence Submitter name, address, contact Roche Diagnostics Corporation 9115 Hague Rd Indianapolis IN 46250 (317) 576 3723 Contact person: Priscilla A. Hamill Date prepared: October 28, 1999 Predicate device The ELECSYS β-CrossLaps/serum Immunoassay is substantially equivalent to other devices marketed in the United States. We claim equivalence to the Osteometer Serum CrossLaps™ One Step ELISA (K990843). #### Device name | Proprietary name | ELECSYS® β-CrossLaps/serum Immunoassay | |---------------------|-----------------------------------------------------------------------------------| | Common name | Electrochemiluminescence Immunoassay, β-CrossLaps / Serum | | Classification name | Column Chromatography & Color Development, Hydroxyproline | {1}------------------------------------------------ and the comments of the country and the comments of the comments of | Device description | The ELECSYS® β-CrossLaps/serum Test is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code card. | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma. | | Indication for use | • For assessing individual bone resorption • As an aid in monitoring anti-resorptive therapies (eg. bisphosphates, hormone replacement therapy-HRT) in postmenopausal women and individuals diagnosed with ostepenia | | Substantial equivalence | The ELECSYS® β-CrossLaps/serum Immunoassay is equivalent to other devices legally marketed in the United States. We claim equivalence to the Osteometer Serum CrossLaps™ One Step ELISA (K990843). | . {2}------------------------------------------------ Substantial equivalence similarities The following table compares the ELECSYS® ß-CrossLaps/serum Immunoassay with the predicate device. | Feature | ELECSYS® β- CrossLaps/serum Immunoassay | Predicate Device | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | for the quantitative determination of degradation products of type I collagen | for the quantitative determination of degradation products of C-terminal telopeptides of type I collagen | | Indication for use | For assessing individual bone resorption. As an aid in monitoring anti- resorptive therapies (bisphosphonates or hormone replacement therapy HRT) in postmenopausal women individuals diagnosed with osteo-penia | Diagnosis of human bone resorption as an aid in: Monitoring bone resoprtion changes under hormone replacement therapy (HRT) or bisphosphonate therapy in Anti-resorptive therapies in postmenopausal women Anti-resorptive therapies in individuals diagnosed with osteopenia Predicting skeletal response (Bone Mineral Densitiy) in postmenopausal woman undergoing anti- resorptive therapies | {3}------------------------------------------------ : | Feature | ELECSYS® β- CrossLaps/serum Immunoassay | Predicate Device | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Specimen collection | fasting morning blood samples are recommended longterm investigations: samples should be always taken under the same conditions as the baseline sample | fasting morning blood samples are recommended longterm investigations: samples should be always taken under the same conditions as the baseline sample | | Sample type | Human serum and plasma | Human serum and plasma | | Antibodies | 2 monoclonal antibodies against the amino-acid sequence of EKAHD-β- GGR | 2 monoclonal antibodies against the amino-acid sequence of EKAHD-β-GGR | 11:00 PM Substantial equivalence – similarities, continued {4}------------------------------------------------ Substantial equivalence differences The following table compares the ELECSYS® ß-CrossLaps/serum Immunoassay with the predicate device. | Feature | ELECSYS® β- CrossLaps/serum Immunoassay | Predicate Device | |-----------------------------------|-------------------------------------------------------------------------------|------------------------------------------| | Assay protocol | 2-step sandwich assay | 1-step sandwich assay | | Detection protocol | Electrochemiluminescence | ELISA/Absorbance reading | | Instrument | ELECSYS® 2010 and 1010 Immunoassay Analyzers | Microtiter Plate Reader | | Procedure | Automatic | Manual | | Measuring range | 0.010 – 6.00 ng/mL | 94 – 20,000 pM | | Traceability / Standardization | Internal reference standards (purified peptide): traceable by weight | No information in the package insert. | {5}------------------------------------------------ Substantial equivalence performance characteristics The Performance characteristics of the ELECSYS® ß-CrossLaps/serum Immunoassay and the predicate device are compared in the table below. | Feature | ELECSYS® β-CrossLaps Test System | Predicate Device | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Within-Rum precision (%CV) | Human sera: 4.6% at 0.08 ng/mL 1.8% at 0.39 ng/mL 1.0% at 3.59 ng/mL Controls: 3.4% at 0.15 ng/mL 1.6% at 0.84 ng/mL 2.2% at 3.18 ng/mL | Serum samples: 5.4% at 1737 pM 5.0% at 2694 pM 5.1% at 3415 pM | | Total precision (%CV) | Human sera: 4.7% at 0.08 ng/mL 4.3% at 0.39 ng/mL 1.6% at 3.59 ng/mL Controls: 3.4% at 0.15 ng/mL 1.9% at 0.84 ng/mL 2.5% at 3.18 ng/mL | Serum samples: 8.1% at 1963 pM 5.4% at 2820 pM 6.5% at 3503 pM | | Analytical sensitivity | 0.01 ng/mL | 94 pM | | Feature | ELECSYS® β-CrossLaps Test System | Predicate Device | | Limitations | No interference from bilirubin up to 65 mg/dL No interference from hemoglobin up to 0.5 g/dL No interference from intralipid up to 1500 mg/dL No interference from biotin up to 90 ng/mL No interference from rheumatoid factor up to 1500 U/mL No high dose hook effect up to 150 ng/mL | No interference from ditaurobiliribin up to 60 mg/dL No interference from hemoglobin up to 1.0 g/dL No interference from intralipid up to 1000 mg/dL | | On-board stability | ELECSYS® 2010: 8 weeks ELECSYS® 1010: 4 weeks (stored alternately in the refrigerator and analyzer at ambient temperature 20-25°C; up to 20hr opened in total) | NA | | Calibration frequency | ELECSYS® 2010: after 1 month (same lot) after 7 days (same kit) ELECSYS® 1010: with every reagent kit after 7 days (20-25°C) after 3 days (25-32°C) | Calibration with each run | {6}------------------------------------------------ : : ## Substantial equivalence – performance characteristics, continued : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . : {7}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. #### JUL 2 4 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Priscilla Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, Indiana 46250-0457 Re: K993706 > Trade Name: Elecsys® Serum B-CrossLaps/serum Immunoassay Regulatory Class: I reserved Product Code: JMM Dated: June 16, 2000 Received: June 19, 2000 Dear Ms. Hamill: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {8}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html". Sincerely yours, Steven Gutman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT 510(k) Number (if known): NHA K99370 C Device Name: ELECSYS® Serum β-CrossLaps/serum Immunoassay Indications For Use: For the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma, for assessing individual bone resorption. The test may be used as an aid in monitoring anti-resorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The elecrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche ELECSYS 1010 and 2010 immunoassay analyzers. Dean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 4993706 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1 - 2-96)