(265 days)
No
The description details a standard immunoassay technology (ECLIA) and calibration method, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used for in vitro quantitative determination of degradation products for assessing bone resorption and monitoring anti-resorptive therapies; it does not directly treat or prevent a disease.
Yes
The device is described as aiding in monitoring anti-resorptive therapies and performing quantitative determination of degradation products, which are diagnostic functions.
No
The device description clearly states it is an electrochemiluminescence immunoassay intended for use on specific Roche immunoassay analyzers, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It also specifies the analysis of human biological samples (serum and plasma).
- Device Description: The description details an "electrochemiluminescence immunoassay" which is a laboratory-based test performed on biological samples.
- Regulatory Context: The mention of a "Predicate Device(s)" with K numbers (K990843) strongly suggests this device is undergoing or has undergone regulatory review as an IVD. K numbers are associated with FDA submissions for medical devices, including IVDs.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma.
• 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
Product codes
JMM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
postmenopausal women
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document provides performance characteristics including within-run precision (%CV), total precision (%CV), and analytical sensitivity for both the ELECSYS® β-CrossLaps Test System and the Predicate Device.
Within-Run Precision (%CV) for Human sera: 4.6% at 0.08 ng/mL, 1.8% at 0.39 ng/mL, 1.0% at 3.59 ng/mL. For Controls: 3.4% at 0.15 ng/mL, 1.6% at 0.84 ng/mL, 2.2% at 3.18 ng/mL.
Total Precision (%CV) for Human sera: 4.7% at 0.08 ng/mL, 4.3% at 0.39 ng/mL, 1.6% at 3.59 ng/mL. For Controls: 3.4% at 0.15 ng/mL, 1.9% at 0.84 ng/mL, 2.5% at 3.18 ng/mL.
Analytical sensitivity: 0.01 ng/mL.
Limitations: No interference from bilirubin up to 65 mg/dL, hemoglobin up to 0.5 g/dL, intralipid up to 1500 mg/dL, biotin up to 90 ng/mL, rheumatoid factor up to 1500 U/mL. No high dose hook effect up to 150 ng/mL.
On-board stability: ELECSYS® 2010: 8 weeks; ELECSYS® 1010: 4 weeks.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: 0.01 ng/mL
Within-Run 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.
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1400 Hydroxyproline test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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)